Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Technical Operations BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients Executive Operations Coordinator - Global External Operations Reporting to Vice President Global External Operations Dublin - Hybrid Closing date Tuesday 12th March Reporting to VP Global External Operations, the Executive Operations Coordinator duties will be varied and complex in nature. We are seeking a proactive and data-driven executive coordinator to provide exceptional executive support, while leveraging digital tools anddata insights to optimize role goes beyond traditional administrative support, requiring a proficient individual who can organize, analyze and present information in ways that enhance decision-making and drive team efficiencies. If you are detail oriented, digitally savvy and excited about supporting leadership with data-driven insights, we would love to hear from you. Executive Operations Coordinator will be responsible for the following: Executive Support - Provide high-level administrative support to theVP, GEO - drive communication standardization (e.g. tools and templates). Given the role is accountable to support a global team, calendar management is critical. Calendar management and optimization anticipating potential conflicts and site priorities is a key deliverable. Schedule and coordinate meetings and events with a proactive approach that supports leadership priorities and seamless execution. Partner with the Head of Strategy and Business Operations to support site meetings, advance objectives and ensure alignment with site leadership priorities Executive Global Travel Management - Own end-to-end global travel planning and coordination for VP, GEO, including complex multi-leg itineraries, time-zone optimization, contingency planning, policy compliance, and real-time issue resolution to ensure seamless executive and minimal business disruption. Information Management - Maintain and manage internal communication channels, including BioWeb, Teams, digital signage. Manage Teams folders, ensuring information is organized, current, and accurate. Project and Program Support - Support the planning, coordination and execution of identified projects across the site. Prepare agendas, PowerPoint presentations, project plans, schedules and trackers to meet project milestones, identify deliverables and manage risks. Support cross functional communication. Monitor opportunities for continuous improvement of project management tools and processes Event Management - Lead all logistics for Town Halls, BMRN conferences, on-site/off-site meetings, community outreach and social events. Manage budget, event communications, agendas, timelines, and post-event evaluations. Communications - Partner with Head of Strategy and Business Operations, Global Manufacturing, and Corporate Communications to ensure compliance and alignment of messaging. Responsible for digital communications ensuring compliance with Social Media communications policies. Collaboration - Lead and partner with other EAs to ensure planned interactions and travel plans of their Executives are coordinated when plans intersect throughout the year. Coordination - Build, coordinate, and manage an annual calendar synchronized with key stakeholders. Help coordinate on-site/off-site global events, ensuring related logistics are effectively managed and stakeholder needs are met. Technical Proficiency - Skilled in office software, virtual collaboration platforms, and able/willing to adapt to new technologies and tools. In addition to being professional, discrete and courteous, the Executive Coordinator must possess: A proven ability to perform as an Executive Coordinator Quick learner and self-starter capabilities -- able to work proactively and independently on tasks Strong calendaring skills and catering/meeting planner capabilities Strong communication skills on all levels with executive leaders, employees, and outside vendors Responsiveness to deadlines, excellent attention to detail, and able to prioritize multiple tasks A high level of professionalism with strong influencing skills and ability to anticipate situations or issues Independent judgment and discretion with sensitive/confidential employee information A can-do attitude, ability to be flexible and adaptable Ability to receive and act on "ad-hoc" requests Ability to think creatively and strategically A team-oriented work style Ability to periodically respond to requests outside of normal business hours Ability to travel 5-7 times per year or as needed. Requirements: 5+ years of executive level support VP, S/EVP, or C-level and office administration Strong PC computer skills with proficiency in Microsoft Office Suite (Word, Teams, Outlook, PowerPoint), Concur expense reporting, travel suite booking tools and project management software Bachelor's degree preferred Experience working within Biotech Industry preferred Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Technical Operations BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Who We Are BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Warehouse Shift LeadOnsite - 2 Shift Pattern (Mon-Fri)Shanbally, Ringaskiddy CorkClosing Date: 6th Mar 2026 The Warehouse Shift Lead will serve as an integral member of Warehouse Operations based in a biologics facility which incorporates drug substance manufacturing, labelling & packaging of finished product, Fill Finish operations along with global supply co-ordination and product launch. The Warehouse Shift Lead will fulfil a key role by coordinating the Shipping, Receiving, Warehouse and 3PL team in support of the plant's material operations requirements for steady - state manufacturing, packaging, fill finish and new product introductions (NPI). In addition, the Warehouse Shift lead will have oversight of receiving activities executed at BioMarin third party logistics (3PL) partners and will act as liaison between the 3PL and BioMarin stakeholders with regards to any raw material issues and support requirements. This varied role includes the coordination of 3PL inventory replenishment, maximizing on site storage and capacity utilization, resource planning for standard work, and team coordination to ensure all tasks are completed and targets are achieved and updated/tracked on the area Daily Management Standard Workboard. The role calls for strong time management and prioritization skills. Ideally, the successful candidate will have experience and understanding of Materials Management in a Biotechnology or Pharma environment with particular focus on maintaining GMP standards. The successful candidate will be an enthusiastic and energetic person with an ability to prioritize and co-ordinate multiple tasks across multiple activities in an everchanging environment. Attention to detail is critical in this operating environment. Strong and effective communication skills will be necessary, as well as the ability to positively influence without authority. This role will report to the Supply Chain Operations Team Lead. Key Responsibilities Develop and demonstrate a proactive approach to safety, industrial hygiene, environmental and regulatory compliance Co-ordinate the Receiving, Warehouse, Weigh and Dispense and Sampling teams within Warehouse by maintaining Daily Management Standard work boards and giving clear direction to the team Ensure adherence to the Receiving, Warehouse, Weigh and Dispense and Sampling schedules Collaborate with Supply Chain Operations colleagues, QA, QC, Manufacturing, Packaging and Engineering to ensure all KPI's, SLA's and departmental targets are achieved Responsible for material management and storage, 3PL Inventory management and fulfilment of inventory requirements at BioMarin Shanbally Responsible for ensuring adherence to schedules for Manufacturing, Fill Finish and Packaging operations Co-ordinate both local and offsite facilities to ensure inventory supply is efficiently maintained for Shanbally, and replenishment signals are reviewed regularly to ensure they are in line with activity Maximize capacity efficiency of warehouse and cold-rooms/Freezers. Oversee all cycle counting activities at the Shanbally and satellite warehouse facilities Area Lead for regulatory inspections Perform updates to standard operating procedures, training modules and compliance requirements Maximise efficiency through continuous improvement and progressive thinking Ensure temperature - controlled areas within Warehouse Operations are maintained within compliance Ensure all weekly tasks are completed on time and in full Ensure housekeeping and 5S practice standards are maintained to the highest levels. Timely escalations of any issues or concerns to Supply Chain Operations Leadership Team Act as a role model for the values and behaviours of BioMarin Shanbally in a dynamic and fast paced working environment The execution of the above activities will often be to very exacting timelines and will require interaction with key collaboration partners in different time zones Other duties as assigned. Skills Demonstrated experience working with in a cGMP environment Leadership experience and demonstrated ability to successfully influence team performance in a high-performance team is preferred Strong demonstrated ability in communication and strong ability to interact across cross-functional teams Demonstrated ability to train and coach colleagues in processing, operational excellence, team interactions and delivering results. Strong process knowledge of warehouse and 3PL operations Strong process knowledge in ERP systems, preferably SAP (SAP S4 Hana) Excellent co-ordination and prioritisation skills Strong continuous improvement focus Strong collaboration skills Experience with regulatory inspections Equipment Should be proficient in the operation of all equipment used in the respective functional area of responsibility. Education Degree in Science/Engineering, operations management or industrial engineering preferred. Other continuing education initiatives highly desirable (e.g. Six Sigma, Lean Manufacturing, industry specific coursework) Experience At least 5 years' leadership experience in warehouse operations in a regulated manufacturing environment with excellent knowledge of supply chain operations. Experience with ERP and WHMS, preferably SAP S4 Hana Demonstrated ability to partner with other functional groups to achieve business objectives Strong knowledge of cGMPs (US & EU), OSHA, ISO, and other regulatory agency standards and requirements applicable to warehouse operations in a pharmaceutical production facility. Strong communication and interpersonal skills - oral, written and formal presentation skills Creative problem-solving skills Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Corporate Groups It takes a village, and at BioMarin our corporate groups are the people behind our success. Groups such as IT, Finance, Legal, Global Compliance & Ethics, and our People Team provide foundational support of all areas of operation at BioMarin. Senior Manager - Financial Planning & Analysis (FP&A) Hybrid- (Minimum 2 days on site DUB) Closing date 10th March 2026 BioMarin is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children. These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options. BioMarin will continue to focus on advancing therapies that are the first or best of their kind. By providing a foundation for all operations company wide, BioMarin's General and Administrative teams support our mission of providing first and best in class therapeutics to patients who live with rare diseases. Our teams include groups such as finance, legal, human resources, corporate compliance and ethics, and information technology. Come join our team and make a meaningful impact on patients' lives. SUMMARY DESCRIPTION BioMarin Financial Planning & Analysis (FP&A) teamis seeking a highly motivated Senior Manager to join their team. This position will be a key member of a cross-functional, multi-national team supporting BioMarin's Enzyme Therapies Business Unit cross functionally, with an emphasis on the Commercial organisation. The successful candidate will gain significant exposure to business operations, strategic decision-making processes and key Executive Leadership, contributing to the development and execution of business strategies. Responsibilities: The FP&A team is responsible for the consolidation, reporting, and analysis of the company's budget and forecasts for both Revenue and Operating Expenses (OpEx). The Senior Manager will lead various aspects of FP&A, including: Revenue Planning & Forecasting Lead the end-to-end revenue planning cycle, including annual budgets, quarterly forecasts, and long-range planning, ensuring alignment with commercial and corporate FP&A teams. Lead financial analysis and forecasting activities for specific regions and global consolidation Develop robust revenue models that incorporate market dynamics, pricing strategies, product lifecycle considerations, and pipeline assumptions Develop understanding of sales and spending trends to manage financial risk and identify opportunities. Partner with commercial and business unit leaders to validate assumptions, challenge inputs, and ensure accuracy and transparency in revenue projections. Performance Management & Results Reporting Own monthly and quarterly performance reporting, delivering clear, insightful analysis of revenue performance, variances, and key business drivers. Collate regional narratives for board and management reporting. Prepare executive-level dashboards and presentations that translate complex financial data into actionable insights for senior leadership. Monitor KPIs across therapeutic areas, product portfolios, and markets, highlighting risks, opportunities, and trends that impact financial performance. Business Partnering & Strategic Support Act as a strategic finance partner to commercial, supporting decision-making with data-driven insights, also collaborating with R&D, Technical Operations (TOPS), supply chain and corporate functions Provide scenario modelling and sensitivity analysis to support revenue forecasting decisions, launch planning, lifecycle management, and investment prioritisation. Support strategic initiatives such as new product launches, market expansion, licensing deals, and portfolio optimisation. Business Case Development & Investment Analysis Prepare and evaluate business cases for new product launches, lifecycle investments, capital projects, and commercial initiatives. Conduct NPV, IRR, and scenario modelling to assess financial viability and risk. Diagnose business challenges, identify gaps, and recommend financially sound approaches. Financial Governance & Process Excellence Drive continuous improvement in forecasting accuracy, reporting processes, and financial systems to enhance efficiency and data quality. Ensure compliance with internal controls, corporate policies, and industry-specific financial reporting standards. Mentor and guide junior FP&A team members, fostering a culture of analytical excellence and collaboration. QUALIFICATIONS AND EXPERIENCE: Education: Bachelor's degree in Finance, Accounting, Economics, or a related field; ideally supported by a professional accountancy qualification (e.g. ACA, ACCA, CFA), Minimum 8 years' PQE in an FP&A role, preferably in Pharmaceutical/ Medtech/ Biotech Experience: Proven experience in financial analysis, reporting, and budgeting, preferably in a corporate/commercial finance environment, ideally in Pharmaceutical/ Medtech/ Biotech Systems: Energetic, organized and highly skilled with systems, applications and platforms (Hyperion, SAP, PowerBI, Excel, PowerPoint, SharePoint, Microsoft Teams, Anaplan etc.) REQUIRED SKILLS: Analysis: Strong analytical skills, proficiency in Microsoft Excel, and familiarity with financial software and modelling techniques. Communication: Excellent verbal and written communication skills, with the ability to convey complex financial information clearly. Leadership: Lead cross-functional projects, with proven ability to influence and build trust with stakeholders at all levels Accountability: Independent worker and self-starter that enjoys problem solving and takes pride and accountability in their work product Prioritisation: Ability to manage various tasks, priorities and timelines and able to adapt quickly to changing circumstances BENEFITS: Competitive salary Bonus Healthcare (health, vision, dental) Life & critical illness cover Pension 25 days annual leave Hybrid: 2 days per week in Dublin office Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Technical Operations BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Project Manager, Product Supply Chain Shanbally, Ringaskiddy, Cork Summary Description: Over sees and leads projects in support of early programs Product Supply Chain Teams and Commercial Value Chain Teams, ensuring they are completed on time, within budget, and to the required quality standards. This role involves planning, executing, and closing out projects, managing teams, and collaborating with various stakeholders. Key responsibilities include developing project plans, managing budgets and schedules, mitigating risks, and ensuring compliance with regulations. Responsibilities: Project Planning and Execution: Developing detailed project plans, timelines, and resource allocation strategies Budget & Schedule Management: Monitoring project costs, tracking spending, and ensuring projects stay within budget and on schedule Risk Management: Identifying potential risks and developing mitigation strategies to minimize their impact Team Leadership: Leading and motivating project teams, fostering collaboration, and ensuring effective communication. Stakeholder Management: Maintaining strong relationships with stakeholders, providing regular updates, and managing expectations Compliance and Quality Assurance: Ensuring projects adhere to relevant regulations, standards, and quality requirements Documentation and Reporting: Maintaining accurate project documentation and providing regular progress reports to stakeholders Closeout and Evaluation: Overseeing project closeout activities, including final reports, financial reconciliation, and lessons learned Scope: Developing project proposals and cost estimates. Creating and maintaining project schedules, including milestones and deadlines. Conducting regular project status meetings and providing updates to stakeholders. Managing project scope changes and ensuring they are properly documented and approved. Ensuring that all project deliverables meet the required quality standards. Managing project budgets and ensuring that spending is within the allocated limits. Managing project risks and developing mitigation plans. Leading and motivating project teams, including engineers, scientists, and other professionals. Communicating with stakeholders, including clients, senior management, and regulatory agencies. Education: Required: bachelor's degree in a relevant field (e.g., science, engineering, or project management) is t required. Preferred: A master's degree or relevant certifications (e.g., PMP) Experience: Project Management Expertise: 5-8 years of demonstrated experience in managing complex projects, preferably in the life sciences industry. Leadership Skills: Ability to lead and motivate teams, manage conflicts, and foster collaboration. Communication Skills: Excellent verbal and written communication skills, with the ability to effectively communicate with stakeholders at all levels. Analytical and Problem-Solving Skills: Ability to analyze complex situations, identify problems, and develop effective solutions. Technical Proficiency: Understanding of relevant technologies, processes, and regulations within the life sciences industry. Financial Acumen: Understanding of project budgeting, cost control, and financial reporting. Regulatory Knowledge: Familiarity with relevant regulations, such as GMP, FDA regulations, and other industry-specific standards. Approximately 15% travel Contacts: TOPS and PSCT product teams, GSC Planning, Site SC and Operations, Regulatory, Commercial Ops., Master Data team, Logistics, Artwork / Packaging Operations, Quality, Finance and other functions as necessary Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Technical Operations BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Training & Compliance Specialist Hybrid - 3 Days Onsite Shanbally, Ringaskiddy Cork Closing date 6th March The Role:The Training & Compliance Specialist will perform functional administration activities on learning systems and reporting tools for various training functions, including Quality, Manufacturing and Supply Chain.This role works closely with the Department Training Admins/Coordinators/Specialists across BioMarin to drive the training process, implement training solutions, and triage requests/needs. As a member of the Training Compliance Excellence Team, you will work with the business to facilitate the planning and implementation of training, assess needs, generate/distribute metrics, maintain procedures, monitor effectiveness, enable process improvement, and support QMS activities for training compliance. This role will also periodically conduct live training for key stakeholders. What you will do:Business Partnership Partner with Department Team Leads and related personnel, to assess training needs for their functional area(s) of responsibility; assist in translating needs into training requirements/solutions. Partner with various functional groups (e.g., Manufacturing, Quality, Regulatory, Compliance, HR, etc.) to incorporate functional-based training programs into the role-based curriculums, as appropriate. Own and support actions for Deviations/CAPAs related to the Training System and LMS. Investigate, or recommend systemic improvements to the training system. Represent LMS processes during regulatory body audits/inspections and support requests for training records and/or evidence for qualification. Document training records and manage assignment requests in learning management system(s) Support Learning and Development Improvement Projects as required. Create and manage job aids and work instructions as they relate to the LMS and Training processes Provides back up support and coverage to other Training Compliance Specialists Contribute to Training Website and Webpages - curating content and maintaining site contents and calendar(s) Provide troubleshooting support for LMS assignments and items for complex issues Perform additional duties as assigned. What you will need: Bachelor's degree in the area of Business, Training & Development, Education, Quality, or Human Resources related discipline. Experience supporting training processes for Pharma organization preferred. Experience with learning applications, integrated human resources applications or integrated document management applications is preferred. Experience creating/distributing metrics reports. Knowledge of training needs analysis, instructional/program design, development and evaluation, adult learning concepts and learning methodologies. Ability to influence management, business groups, and Subject Matter Expert (SME)'s toward a recommended thought or action. Good analytical and problem-solving skills. Ability to support various local projects and work well in a fast-paced environment. Proven customer service, organizational and team collaboration skills. Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Technical Operations BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Supply Chain Operations Warehouse PlannerShanbally, RingaskiddyOnsite Days RoleDuties The Warehouse Planner will work in a team environment that is aligned with the Supply Chain Operations (SCO) team and will be committed to continuous improvement, process understanding, personal development, and demonstration of process techniques that will result in agile and compliant supply chain operations. Main areas of responsibility: Manage stock levels on SAP across multiple warehouses including 3PLs, ensuring the correct inventory mix to support picking activities. Oversee internal customer orders and internal stock requests, allocating stock and releasing orders for picking for Drug Substance, Drug Product and Packaging operations. Coordinate with external partners and internal teams to schedule deliveries efficiently and cost-effectively. Track and coordinate incoming and outgoing shipments to ensure raw materials/inbound product and finished goods are delivered correctly. Support inventory management and cycle counting activities. Participate and support inventory optimization that helps create a strong value proposition for future investment. Provide weekly and monthly reports, planning schedules, and other required documentation. Planning of daily material operations activities for Warehouse Technicians, Biotechnicians and Shift Leads. Support Shift Leads and Biotechnicians on materials operations processes, use of operational excellence tools, and high-performance team behaviors. Support daily material operations under cGMP conditions. Support business process excellence implementation within Supply Chain Operations (e.g. Daily Management System (DMS), 5S, SMED, Leader Standard Work, Cross training, PPM & Standard work). Strong focus of visibility boards for Supply Chain Operations metrics and daily operations. Ensure schedule adherence, assist in troubleshooting and facilitate appropriate escalation. Support and partner closely with the Supply Chain Operations Managers, Team Lead, shift leads and biotechnicians, Drug Substance, Drug Product and Packaging colleagues. Participate in cross-functional teams, as applicable, to troubleshoot and resolve technical issues using root cause analysis tools. Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance. Lead and implement continuous improvement initiatives and productivity and value enhancement projects for Supply Chain Operations. Lead the execution of Supply Chain Operations readiness plans for manufacturing campaigns for new and existing products. Own, investigate, write and approve associated deviations as well as supporting and coaching Biotechnicians in these functions as required. Supervise, and perform as needed, employee training in Warehouse Operations. Coach, mentor and train team members on area processes, procedures, use of operational excellence tools, and high-performance team behaviours. Skills Demonstrated planning and scheduling experience working with device assembly, secondary packaging and manufacturing operations in a cGMP environment Experience with 3PL operations including material management and storage, 3PL inventory management and fulfilment of inventory requirements Experience and demonstrated ability to successfully influence team performance in a high-performance team is preferred Strong demonstrated ability in communication and strong ability to interact across cross-functional teams Demonstrated ability to train and coach colleagues in processing, operational excellence, team interactions and delivering results. Strong process knowledge of supply chain operations and SAP S4 Hana Excellent project management skills Proven ability to lead and deliver on multiple and agile and flexible to work on multiple initiatives Strong continuous improvement focus Strong collaboration skills Demonstrated ability to train and coach colleagues in processing, operational excellence, team interactions and delivering results Experience with regulatory inspections Equipment Should be proficient in the operation of all equipment used in the respective functional area of responsibility. Education Degree in science/engineering, operations management or industrial engineering required. Other continuing education initiatives highly desirable (e.g. Six Sigma, Lean Manufacturing, industry specific coursework) Experience At least 3 years planning/scheduling experience in a regulated manufacturing warehouse environment with excellent knowledge of material operations. Excellent knowledge of ERP and WHMS systems, preferably SAP (SAP S4 Hana) Demonstrated ability to partner with other functional groups to achieve business objectives Strong knowledge of cGMPs (US & EU), OSHA, ISO, and other regulatory agency standards and requirements applicable to material operations in a pharmaceutical production facility. Strong communication and interpersonal skills - oral, written and formal presentation skills Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Technical Operations BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. AssociateDirector:Sterility Assurance Lead Location:BioMarinShanballySite (with global interaction across the BioMarin network) Reports To:Site Quality Lead Associate Director: Sterility Assurance Lead Location: BioMarin Shanbally Site (with global interaction across the BioMarin network) Department: Quality Reports To: Site Quality Lead ROLE BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These individuals build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Position Overview We are seeking a Sterility Assurance Lead to join our Quality organization at BioMarin Shanbally as we expand our manufacturing facility and commence commercial Drug Product (DP) manufacturing operations for global markets. This is a critical leadership role responsible for ensuring that all marketed and investigational drug products manufactured at our site meet the highest sterility and contamination control standards. The successful candidate will act as a key influencer across the site and global operations, shaping contamination control strategies and driving compliance with regulatory expectations. This is an exciting opportunity for a proactive leader to define and implement sterility assurance programs, collaborate cross-functionally, and represent the site as a subject matter expert during audits and inspections. Key Responsibilities Strategic Leadership: Own and continuously evolve the site's Contamination Control Strategy, ensuring alignment with global standards and regulatory requirements. Regulatory Compliance & Influence: Implement regulatory expectations, maintain compliance with EU GMP Annex 1, 21 CFR, USP, EP, JP, and ICH guidelines, and stay current with emerging regulations and best practices. Training & Culture: Design and deliver robust training programs on aseptic processing, behaviors, and contamination control principles to embed a culture of sterility assurance across the site. Environmental Monitoring & Utilities: Establish and maintain environmental monitoring and clean utilities programs, ensuring proactive contamination control. Technical Expertise: Provide expert input on gowning, cleaning, sanitization strategies, microbiological method transfers, and contamination investigations. Investigations: Lead and guide the investigation of contamination-related deviations, non-conformances, and sterility failures. Perform root cause analysis, define corrective and preventive actions (CAPAs), and ensure timely closure of quality events. At the Shanbally site and within Global Operations. Data Analysis & Risk Mitigation: Review microbiological data trends, identify risks, and implement effective mitigation strategies. Global Collaboration: Partner with global Technology and Quality functions to ensure site alignment with industry best practices and BioMarin network standards. Continuous Improvement: Drive initiatives to enhance microbiological quality, operational efficiency, and inspection readiness. Facility Expansion Support: Lead microbiology aspects of facility expansions, including cleanroom qualification and sterilization systems. Qualifications & Experience Education: Bachelor's degree in Microbiology, Biology, Pharmaceutical Sciences, or related discipline (Master's or PhD preferred). Experience: 10-15+ years of progressive experience in microbiology within GMP-regulated pharmaceutical or biotechnology environments. Minimum 5 years in leadership roles, with proven ability to influence cross-functional teams and senior stakeholders. Significant hands-on experience supporting aseptic sterile fill-finish operations. Strong knowledge of EU GMP Annex 1 and global sterility assurance standards. Demonstrated success in leading contamination investigations and regulatory interactions. Skills: Strategic thinker with strong problem-solving and decision-making abilities. Excellent communication and influencing skills across all organizational levels. Ability to interpret complex microbiological data and translate into actionable strategies. Why Join Us? This is a high-impact role at the heart of BioMarin's mission to deliver life-changing therapies. You will have the opportunity to shape sterility assurance practices globally, lead critical initiatives, and work with a team committed to excellence and innovation. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Technical Operations BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Job Title: Logistics Manager EUMEA Reports to (Job Title): Associate Director, Regional Logistics Leader Location: Cork, Ireland Work Type: Contract 1 Year Summary Description: The Global Logistics Manager is responsible for managing intercompany Clinical and Commercial drug substance, drug product, and finished good material movements from order placement through to final delivery. This position supports the planning and distribution of BioMarin Pharmaceutical products to and from third party manufacturing, packaging, and distribution facilities globally. In executing these shipments, the Global Logistics Manager will be required to demonstrate Good Distribution Practices, export/import compliance, and transportation management activities globally. The manager will execute logistics activities and will serve as a liaison between various internal and external partners to ensure the timely planning and delivery of orders. Additionally, the Global Logistics Manager will participate in the process analysis and continuous improvement activities. Note that individual responsibilities may include all or part of responsibilities defined below depending on individual experience and abilities and may change to best support on-going business needs. Responsibilities: Accountable for the day-day operational Logistics planning. Further development of internal and external relationships through effective communication. Ownership and accountability for the day-to-day planning, execution activities and Order-to-cash activities. Co-ordinate with the Global Supply Chain Planners and External Operations Teams for temperature-controlled shipping and delivery between contract manufacturing operations, packaging sites, distribution centers and customers Establish standardized material movement practices and protocols. Establish and maintain transparent transport planning schedule with proactive tracking of deliveries. Work with Global Trade Compliance to maintain appropriate documentation to support accurate reporting to government customs agencies Works on assignments that are complex in nature where considerable judgment and initiative are required in resolving problems and making recommendations. Support the creation and implementation of best practices and fit-for-purpose work instructions (WIs), risk assessments (RAs), and standard operating procedures (SOPs). Drive continuous improvement initiatives reflecting evolving business development and general projects. Implement strategies to enhance operational efficiency and effectiveness. Build and develop relationships with key internal and external partners to support the compliant and efficient movement of BioMarin material. Ensure compliance with cold chain and GDP requirements. Complete QMS records for deviations and change controls related to activities at external partners. Ensure adherence to quality standards and regulatory requirements. Execute transactions within the appropriate ERP for timely inventory and financial recognition Will support projects as required. Other duties as assigned Scope This role is responsible for supporting the efficient movement and storage of lifesaving therapies in compliance with applicable regulations. Decisions made in this role are of critical nature in mitigating risks for the business while ensuring BioMarin's commercial products are delivered to patients in a timely and compliant manner. The candidate should demonstrate the following attributes: A firm commitment to BioMarin's cultural beliefs and values Consistent track record of exceeding objectives within area of influence Ability to achieve results through others without direct reporting lines Strong problem-solving skills with a global focus both internally and externally Possess a high level of accountability and demonstrate an ability to be a change agent in a highly regulated industry Flexibility and ability to deal with changing priorities without losing sight of the overall business Strong interpersonal, communication and influencing skills working with all levels and within an environment of constant change Proactive and energetic outlook with an unwillingness to accept the status quo Interaction and collaboration with team members, peers and senior management Ability to work independently with strong time management skills Education: Bachelor's degree in Logistics, Supply Chain Management, Business Administration, or a related field. In lieu of above, other undergraduate degree plus continuing education in the logistics or extended supply chain management field required Lean Six Sigma Certification preferred, yellow belt certification highly desired. Experience: Minimum of 5 years of experience in supply chain management, logistics, or warehousing. Strong cross functional leadership skills, excellent communication and interpersonal skills, proficiency in logistics software and systems, and a solid understanding of logistics and supply chain principles. Detail-oriented, analytical thinker, problem-solver, and able to work in a fast-paced environment. Cold Chain experience highly desirable Proven ability to lead change initiatives and drive improvements within and across functions which enable compliance and mitigate risk Ability to effectively work autonomously and independently Experience in SAP Work Environment / Physical Demands The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The employee may frequently be required to sit and talk or hear. The employee is occasionally required to stand; walk; use hands and fingers, handle, or feel; reach with hands and arms; climb or balance; stoop, kneel, crouch, or crawl and taste or smell. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities by this job include close vision, depth perception and ability to adjust focus. Approximately 5% travel Equipment: Standard office desk equipment Contact: Commercial, Site Operations, Clinical Operations, Worldwide Research & Development Scientists, Contract Manufacturing, Quality Assurance, Finance External partners including 3PL providers, transport carriers. Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Technical Operations BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Maintenance Area Lead - PackagingOnsite Role - Shanbally, Ringaskiddy, CorkClosing Date: 27th Feb 2026The Maintenance Area Lead - Packaging is a role based in Maintenance Ops. Reporting to the Utilities and Maintenance Operations Senior Manager, the primary role of the Maintenance Area Lead is to plan, schedule and manage the daily maintenance operations in Packaging; coordinating resources, establishing priorities, being point of escalation for the team and ensuring schedule and deadlines are met. The Maintenance Area Lead will be responsible for maintenance activities in Packaging Areas and support/network with the other Maintenance Area Leads on site. There are synergies between areas, and it is envisaged that some resources may be shared between some areas in due course to ensure the business needs are consistently met. BioMarin has a high-performing, team-based organization, where colleagues are flexible, multi-skilled and empowered to make decisions. A high level of initiative, energy and motivation are key role requirements, as well as excellent organizational skills. Responsibilities: People management of direct reports comprised of Shift technicians, Day Technicians and Apprentices. Responsibility for development, coaching, appraisals and performance management. Addressing Technician and apprentice escalations. Planning & scheduling of Maintenance works in the Packaging Areas will be responsibility of the Maintenance Area Lead - Packaging. Lead to partner with Maintenance Ops Planning and Scheduling (P&S) to ensure works are planned, executed and impact of reactive work minimized. Co-ordinate customer requirements and minimize downtime of plant. Respond to relevant area escalations and assess reactive work requests to maximize both plant and maintenance resource efficiencies Engage in the Continuous Improvement processes and partner with SME's from Engineering team to ensure PM's are optimized. Strong focus on visibility of Maintenance metrics on maximizing plant uptime and CMMS PM compliance. Maintenance Area Lead to enhance team training and development of core competencies, ensuring training and practices are consistent throughout the organization Support optimization of the Apprenticeship Programme Lead and support daily operation of plant and partner with colleagues in designated area departments to ensure equipment is maintained. Instill the use of Right First Time (six-sigma) and lean practices (RCAR,5S etc.) leading to operational excellence. Coach, mentor and train technicians on relevant maintenance works, use of operational excellence tools and instill high performance team behaviours. Proactively maintain Packaging equipment in accordance with cGMP regulations, applicable safety considerations, Standard Operating Procedures, best maintenance practices and the reliability agenda. Manage external vendor support to complete required services in a GMP compliant manner. Ensure systems are maintained in a controlled state thus ensuring compliance with all procedures and regulations and reliability initiatives. Maintain a safe working environment by continuously promoting safety awareness, recognising and rectifying unsafe conditions and performing thorough investigations when accidents occur. Ensure Technicians record all maintenance work performed on the site CMMS system. Ensure Technicians are trained to network with Utility Technicians should issues occur in Packaging Suites. Maintain documentation and management of control systems in compliance with cGMP regulations and training instructions. Network with Planning & Scheduling and Calibration team to ensure calibrations executed where required in timely manner. Contribute to the drive to effectively manage spares, consumables and contracts in a timely and cost-effective manner. Participation in HAZOP and design review (where applicable). Execution of deviations, CAPA's and SIMS (where applicable). Scope: This position ensures the Plant equipment and instrumentation is maintained & operated in the state necessary to perform cGMP activities. Education and Experience: A relevant time-served apprenticeship or third level qualification in Engineering with 5+ years' experience in a GMP environment, preferably Bio-pharmaceuticals or equivalent industry. Demonstrated experience working with MFG processes in production including hands on experience Past experience and demonstrated ability to successfully influence team performance in a high performance team is strongly preferred. Track record of embedding a strong Quality culture. Trackwise experience preferred but not essential. Demonstrate strong communication skills and the ability to interact across cross-functional teams. Demonstrated ability to train and coach colleagues in processing, operational excellence, team interactions and delivering results. Experience with regulatory inspections and direct interaction with regulatory inspectors. Highly developed organizational and leadership skills. Contacts: Work cross functionally to deliver compliant, reliable, efficient and sustainable asset care for internal and external customers or as part of a multidisciplinary project team. Supervisor Responsibilities: Each Maintenance Area Lead of a given functional area will typically have ~10 direct reports; Technicians and Apprentices. The Maintenance Area Leads responsibility including a full rotating 24 hour and weekend shift operations. The role may require the successful candidate to respond to calls to support activities out of hours and process escalations as applicable Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
Who We Are BioMarin is a global biotechnology company that relentlessly pursues bold science to translate genetic discoveries into new medicines that advance the future of human health. Since our founding in 1997, we have applied our scientific expertise in understanding the underlying causes of genetic conditions to create transformative medicines, using a number of treatment modalities. Using our unparalleled expertise in genetics and molecular biology, we develop medicines for patients with significant unmet medical need. We enlist the best of the best - people with the right technical expertise and a relentless drive to solve real problems - and create an environment that empowers our teams to pursue bold, innovative science. With this distinctive approach to drug discovery, we've produced a diverse pipeline of commercial, clinical and preclinical candidates that have well-understood biology and provide an opportunity to be first-to-market or offer a substantial benefit over existing therapeutic options. About Technical Operations BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These engineers, technicians, scientists and support staff build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Engineering Validation Associate - Cork (Onsite) 12 Month Contract The Engineering Validation Associate reports to the Commissioning Qualification and Validation Manager, day to day technical direction may be delegated to the Engineering Validation Team Lead as required, and is responsible for fulfilling validation activities in a GxP regulated environment,including implementation of laboratory systems, newmanufacturingequipment/processesandchangestoexisting equipment/processes. BioMarin's Technical Operations group is responsible for creating our drugs for use in clinical trials and for scaling production of those drugs for the commercial market. These individuals build and maintain BioMarin's cutting-edge manufacturing processes and sites, provide quality assurance and quality control to ensure we meet regulatory standards, and procure the needed goods and services to support manufacturing and coordinating the worldwide movement of our drugs to patients. Key Responsibilities: In collaboration with plant support functions, assist with planning, set up and implementation of Analytical Instrument Qualification, Facilities, Utilities, Equipment (FUE) Qualification and Validation disciplines e.g. FUE Qualification, CSV, New Product Introductions and Change Control. Develop validation plans for specific system implementation projects. Support the establishment of site validation policies, through development, generation and implementation of site validation master plans, guideline documents and standard operating procedures Prepare and track to completion any assigned change requests, deviations, quality events and associated CAPAs. Develop and demonstrate an active approach to safety, industrial hygiene, environmental and regulatory compliance. Assistwithpreparationofregulatoryfilings andparticipation during regulatory inspections/partner audits. Maintain current knowledge of industry standards and regulatory requirements for products developed or manufactured by BioMarin, validation techniques/approaches and systems utilized at BioMarin Lead and represent validation in multi-departmental meetings and project teams. Identifies and implements improvements to the Engineering Validation systems. Coordinatevalidationactivitiesinvolvingcross-functional, multi-departmentalteams including:Manufacturing, Process Sciences, Process Development, Quality Control, Quality Assurance, Regulatory Affairs, and others. Other duties as assigned. Key Requirements: 8- 10 years of Industry Experience. Note: This description is not intended to be all-inclusive, or a limitation of the duties of the position. It is intended to describe the general nature of the job that may include other duties as assumed or assigned. Equal Opportunity Employer/Veterans/Disabled An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability. To be considered for this role you will be redirected to and must complete the application process on our careers page. To start the process click the Continue to Application or Login/Register to apply button below.
