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. 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. Come join our team and make a meaningful impact on patients' lives. QA Associate - Shanbally, Ringaskiddy, Cork (day role) Closing Date - 31st July 2025 This position within the QA department provides Quality oversight, support and knowledge to activities relating to Quality to meet BioMarin business priorities. The QA Associate will have proven capability in promoting Quality across cross-functional teams, to deliver high quality product, ensuring continuous process improvement. The QA Associate will model the BioMarin Leadership behaviours and understand the principles to drive a culture of continuous improvement building a High-Performance Organisation. General QA Associate Responsibilities: Provide Quality input and guidance to ensure Lot Release (Drug Substance and Final Packed Finished Product) of high-quality products in compliance with current Good Manufacturing Practices (GMPs). Compilation of Lot Release Packs as per requirements of SOPs, WIs and related FRMs. Support for the Secondary Packaging Operations team including performance of AQL inspections during routine operations. Provide Quality direction and oversight of the development and continuous improvement of new and existing processes / systems to meet customer needs. Exercise judgment to determine appropriate action, ensuring proper escalation when non-conformances are identified as per applicable procedures for compliance, escalation and corrections. Provide Quality input to Change Control/Deviations ensuring scope of record is clear and implementation activities are robust and timely. Review and approval of Deviations and associated CAPAs for closure ensuring compliance with appropriate documentation, whilst ensuring that CAPA actions address root cause and implementation plan dates are achievable. Participates within inter-departmental and cross-functional teams, with direct interface with Manufacturing, Supply & Distribution, Maintenance, Metrology and Quality Control employees to immediately address issues and questions in real time to help ensure timeline are achieved to meet customer requirements. Minimising impact to Lot Release operations on site. Prioritizes tasks to ensure the critical tasks are completed on time and meet requirements. Review and release inputs for use in manufacturing as required. Write, review and approve Standard Operating Procedures in accordance with BioMarin Policies. Assignments may range from routine to more complex/non-routine projects/assignments, where analysis of situation or data requires a review of identifiable factors within the Lot Release operations area. Coordinates, plans, implements projects within specified objectives Prioritizes tasks to ensure the critical tasks are completed on time and meet requirements. Reviews executed packaging batch records and associated documentation. Participates in customer complaint investigations if required. Provides training and advice to staff in order for them to perform their desired functions. Participation in and leading internal inspections in the Lot Release area of operations. Prepare reports for Product Quality Reviews including batch listing and deviation trend reports to ensure that trends are acted upon and to demonstrate that products consistently meet desired critical quality attributes. QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS REQUIRED: Degree or 3rd level qualification (Science, Quality). Demonstrated experience in Lot Release and Secondary Packaging as the Quality contact for the area. Relevant experience (5yrs +) working in a Quality function in the pharmaceutical or biotechnology industry or other combination of experience and educational background that may otherwise satisfy the other requirements of the role. Demonstrates good knowledge of FDA / EMEA regulations/standards and quality systems. Demonstrated ability to work independently and fully realize improvement initiatives with a moderate level of guidance. Demonstrated ability to work and succeed within teams as well as leading small project teams while maintaining and strengthening trust relationships with people on all levels. Strong organizational skills, including ability to follow assignments through to completion. Proficiency in PC skills such as Excel, Word, PowerPoint. Proven decision-making capability with full accountability and responsibility. Demonstrated coaching skills. Excellent written and verbal communication skills. Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non-Conformance /Deviation investigations. DESIRED: Lot Release experience in the area of Drug Substance, Secondary and Final Packed Drug Product. Experience in execution, documentation and follow-up of in-process inspections for Secondary Packaging processes. Evidence of Continuous Professional Development. Evidence of Validation knowledge/experience. MES experience. Good knowledge of Lean / Continuous Improvement practices and root cause analysis. BEHAVIOURS: Always focused on the patient and customer needs. Resilient profile with the ability to deliver in a challenging environment. Ability to engage and manage multiple stakeholders to achieve the objective. Curious with learning agility. Operationally excellent, with attention to detail. Organised with systematic approach to prioritisation. Process orientated to achieve the business objective We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. 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. 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. 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. Senior Engineer, Drug Product - Cork/Dublin Closing Date: 30th July Technical Development are hiring a Sr Engineer with the following duties: Duties Technical SME for drug product (DP) supporting filling operations, working in a matrix team environment with process development, QA, QC, analytical sciences, packaging, supply chain, and regulatory teams to achieve project objectives. Supporting both Global External Operations (GEO) and Shanbally teams. Develop process comparisons, risk assessments, manage DP technical and manufacturing risks and identify appropriate mitigations. Author technical reports to support DP process and product characterisation. Manage change control, deviations, and CAPAs through the quality management system until closure. Facilitate investigations, root cause analysis for deviation resolution, data gathering/analysis, and provide technical assessments for deviations. Initiate and lead process improvement projects, involving cross-functional teams. Support the technical delivery of new product introductions and tech transfer projects by closely collaborating with cross-functional project teams, ensuring compliance with specifications, regulatory guidelines, and right-first-time delivery. Assist with PPQ campaign readiness and provide in-person, on-the-floor execution support for technical runs and PPQ campaigns as required. Support on-site implementation of changes and DP launch activities. Support aseptic filling operations (vials and pre-filled syringes) for technology transfers and life cycle management, overseeing new product introductions from development batches to approval and commercialization. Assist with regulatory inspections and present technical topics related to process aspects of assigned products when necessary. Ensure a thorough understanding of all quality policies and BioMarin system items as outlined in the training curriculum. Other duties as assigned. Skills Strong understanding and hands on experience in MSAT or process development or technology transfer, background in large scale processing of biologic drug products. Possess a strong understanding and hands-on experience in MSAT, process development, or technology transfer, with a background in large-scale processing of biologic drug products. Have a solid understanding of regulatory requirements and guidelines. Proficient in technical writing. Demonstrated ability to build strong partnerships and work effectively with diverse team members in a dynamic environment. Excellent organizational, interpersonal communication, and problem-solving skills. Capable of identifying, communicating, and implementing continuous process improvements. Ability to multi-task and manage tight timelines in a fast-paced environment. Able to work on the manufacturing floor for extended periods during the execution of technical protocols. Excellent written, verbal, and presentation communication skills. Strong analytical skills and sound judgment. Effective decision-making skills, with the ability to negotiate and balance decisions and priorities across multiple stakeholders' needs. Proficient in MS Office: Word, Excel, Outlook, PowerPoint, MS Project, etc. Education and experience A degree in engineering or science with relevant experience in the biotech/pharmaceutical field. 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, 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. Supply Chain Operations Biotechnician - Ringaskiddy, Cork 12 Month Contract 2 Shift Cycle - Monday to Friday 06.30- 14.30 and 14.30- 22.30 Alternate Weeks Closing date: 14th July 2025 Reporting to the Supply Chain Operations Manager and Supply Chain Operations Lead, the primary role of the Biotechnician will be the day-to-day operation of the warehouse, receiving, shipping, weigh and dispense operations and ensuring all functional areas on site are replenished and supported. This role requires flexibility with regards to work schedules and shift work to support business needs and ability to work at heights. This role will operate within a team environment with an emphasis on safety and quality. The Biotechnician team is committed to continuous improvement, teamwork, personal development and the delivery of best-in-class service in support of Drug Substance manufacturing, Packaging and Fill Finish operations at the Shanbally facility. The role requires customer and patient focus, high adaptability and a proactive collaborative approach to problem solving. The Biotechnician is required to be able to work in an extremely fast paced dynamic environment while ensuring the highest standards of work are maintained 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. KEY RESPONSIBILITIES Demonstrate an active approach to safety, industrial hygiene, environmental, cold chain management and GMP/GDP compliance. Warehouse activities including receiving, 3PL Management, min max picking, move orders, cycle counting, put away of materials, consolidation and general inventory management for; Drug Substance Manufacturing Operations Packaging Operations Fill Finish Operations Supporting shipping including prepping of materials for shipment, pallet wrap and strap, paperwork review and sign off, working with the shipping specialist to ensure schedules are met. Sampling of all raw materials. Weigh and dispense of all raw material kits. Adherence to all departmental, site and company SOP's. Alarm trending and monitoring (Delta V & PI Vision). Responding to equipment alarms and temperature excursions. Flexibility and commitment to respond to emergency temperature alarms. Use, maintenance and scheduled defrosting of product freezers. Efficient management of all inventory between 3PL's and site. Key user of SAP ERP system, specifically materials management modules. Ensure all requests from site are completed on time. Participate in regular inventory, regulatory and internal audits. Create, review and update standard operating procedures where necessary. Record quality records on the internal quality system. Attend and participate in cross functional meetings. Ensure highest level of service to all warehouse internal and external customersensuring SLA's are met with a professional and courteous manner. Successfully collaborate cross functionally with quality operations, facility services, manufacturing, supply chain, packaging and fill finish to ensure efficient materials operations Other duties as assigned Education and Experience Minimum of 2 years experience in a similar role in Pharma, Biotech or Medical Device Sector. GDP and GMP experience highly desirable Demonstrated experience of operating in a fast paced team environment is required. Must be conscientious and proactive with a strong focus and commitment to Quality, Safety and Compliance. Strong teamwork and interpersonal skills Strong communication and problem-solving skills are highly valued. 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'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 Shift Lead - Shanbally, Ringaskiddy, Cork Role The Shift Lead will serve as an integral member of the Supply Chain Operations Group 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 Supply Chain Operations Shift Lead will fulfil a key role by coordinating the Receiving, Warehouse, Weigh and Dispense/Sampling 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 Material Operations 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 & 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 Material Operations 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 Material Operations by maintaining Daily Management Standard work boards and giving clear direction to the Ensure adherence to the Receiving, Warehouse, Weigh and Dispense and Sampling schedules Collaborate with Material 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 Material 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 Material 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. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law. 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. Senior Business Operations Manager - Shanbally, Ringaskiddy, Cork Hybrid Role - 4 days per week onsite Closing date: Wednesday 23rd July 2025 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. BioMarin's Technical Operations group (TOPS) 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. Come join our team and make a meaningful impact on patients' lives. OVERALL PURPOSE OF THE ROLE Reporting into the Director of Business Operations at Shanbally, the Business Operations Senior Manager will be expected to relentlessly drive the business forward while simultaneously increasing their own technical capability through training and experience as well as the capability of others. They will lead the achievement and sustainment of performance excellence, primarily through the use of lean and six sigma methodologies. This role adds value by 1) supporting the business to accelerate the strategic improvement journey and 2) building Operational Excellence capability across the organisation and 3) implementing robust OE infrastructure to sustain the improvement journey. RESPONSIBILITIES Support Leaders across the business to have confidence and control in their performance by: Ownership for the deployment of the DMS system at Shanbally. Prepare an annual DMS improvement plan in collaboration with the business aligned to the site strategy. Challenge the status quo in terms of current performance. Partner with Flow Team Leaders to get the balance right to robustly challenging and support the team to drive the performance improvement agenda. Partner with the leads to implement lean solutions aligned with delivering better control and improved performance across all teams. Key elements for deployment will include visual metrics, performance management, 5S, standard work, LSW and gemba to support the business. Work with the business to optimise the existing governance structure and implement changes to lean, standardise and strengthen the system - evolving with the business changes. Host the annual Site DMS Maturity Assessment to measure progress and identify our next improvement opportunity / focus area. Support Leaders across the business to fix problems by: Own and manage the BioMarin Root Cause (RCAR) program ensuing that the programme is supporting thorough best in class problem solving. Providing regular training to build a community of RCAR expertise across the business. Identify gaps and implement plans to close capability gaps across the site. Identify continuous improvements our overall RCAR process and capture business benefit For complex RCAR (or significant business impact), lead the RCAR team using standardised and specialist tools to identify the correct root cause, fit for purpose effective CAPAs and accelerated implementation plan Lead Value Realisation initiative for the business to embed value and robust COST management across the SQDEC by: Co-lead the Value Realisation program year on year to ensure we have steady stream of projects to achieve savings targets. In collaboration with Finance partner, coach peer across the Flow Team to build their capability on overall management of financial metrics in SQDEC to ensure a balanced scorecard in their Tier structure. Partner with the business lead to tackle waste opportunities and drive efficiencies using structured DMAIC approach Support the business to accelerate the site strategic improvement journey by: Deploy solutions to key business processes on site, aligned with the site strategic improvement plan. Improvement will be delivered in partnership with the business typically through lean, reengineering or Six Sigma. Impact will be measured via improvement in agreed business KPIs. Coach Lean, Reengineering and/or Six Sigma projects as required by the business. Support the Greenbelt programme owner within the BusOps team. Participate actively in Flow Teams on their CI journey to agree improvement priorities. Proactively work with GEO and sister sites NVT and GEO to maintain alignment and share best practices. General maintenance of alignment in methodology, procedure and governance within global organisation (TOPs). Competencies: Cognitive capability - Ability to learn quickly and to be able to share those learnings to wider colleagues in a way that is understandable. Ownership and Accountability - Takes accountability for actions, drives results, and able to learn from mistakes. Delivers on promises, goals, and expectations. Makes quality decisions and resolves problems with minimal delay as appropriate. Asks "what can I do to help?" Collaborative Leadership - Ability to influence with or without authority, facilitate groups with diverse perspectives, bring teams to consensus/alignment. High tolerance for ambiguity and able to create order from chaos. Builds credibility through solid relationships and solid track record of results. Communication - Ability to communicate effectively up and down, at all levels of the organization, present complex and/or new ideas with clarity and simplicity. Ability to draft and deliver clear and concise procedures or business process documents. Planning/Organization - Excellent planning and prioritization skills with the ability to multitask and adapt. Able to synthesize large amounts of information. Able to deliver results despite shifting environment. Analytical Problem Solving - Ability to identify problems, define problem statement clearly and accurately and apply structured and disciplined methodology to identify data-driven root causes. Innovative and effective in solution development, risk mitigation, and execution. Manages expectations. EDUCATION Science, Engineering or Business background preferred but not essential. Formal Lean, Reengineering and/or Six Sigma training preferred but not essential. EXPERIENCE Must have a demonstrated track record in driving performance through self and others by inventively harnessing surrounding (albeit often) constrained resources. A demonstrated track record in working with people, understanding customer/client dynamics and driving positive change. Minimum 10 years of experience in industry. Sound knowledge of cGMPs and equivalent industry regulations. Experience in systems thinking. Knowledge and previous work experience with process mapping, Lean Six Sigma and Business Process Reengineering would be preferable. Knowledge of performance measurement tools and metrics. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. 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. Senior Engineering Validation AssociateShanbally, CorkOnsite RoleClosing Date: 14th July 2025 Summary Description: BioMarin are a high-performing, team-based organization, where colleagues are flexible, multi-skilled and empowered to make decisions. The Engineering Validation team support validation activities across drug substance, drug product and secondary packaging operations. Reporting to the Engineering Validation Team Lead, the Senior Engineering Validation Associate will focus on maintaining the validated state of GMP equipment, facilities, utilities, and systems. Responsibilities: Key Subject Matter Expert (SME) in specific validation discipline(s). Maintains current knowledge of industry standards and regulatory requirements for products developed or manufactured by BioMarin, validation techniques/approaches and systems utilized at BioMarin. Ensures Engineering Validation BioMarin maintains regulatory compliance, in line with industry best-practices in specific validation discipline(s). Leads & supports complex investigations, regulatory submissions, specific regulatory queries and agency inspections in SME areas of expertise. Responsible for strategy development, project management and regulatory compliance for validation projects. Strategically leads and project manages complex validation projects across a variety of disciplines. Responsible for management of internal validation resources during project execution and provision of mentorship and SME support to more junior members of the validation team and cross functional groups as applicable. Identifies and leads implementation of improvements to the Engineering validation system's Executes Validation activities related to the various Validation disciplines. Develops 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. Other responsibilities as assigned. Education: Bachelor of Sciences degree, or higher, in a technical discipline (engineering, chemical or biological sciences) is required. Experience: 5+ years' experience in a cGMP regulated manufacturing environment, with exhibited knowledge and proficiency in validation execution. 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'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. Qualified Person (QP) - Shanbally, Cork - Hybrid Role The Qualified Person (QP) is responsible for fulfilling QP responsibilities in relation to batch release of commercial and clinical product, in accordance with the requirements of 2001/83/EC, 2001/20/EC, Annex 16 and Annex 13 requirements as applicable. The QP ensures all products certified have been manufactured in accordance with the requirements of its marketing authorisation/ CTA and are in compliance with cGMP requirements. Provide technical expertise for all QA and compliance topics /issues relating to manufacturing and product supply of drug product and finished goods. Routinely monitoring the company's operations to ensure compliance with site licenses and Good Manufacturing Practice bringing any critical and major deficiencies to the attention of the Head of Quality Assurance. Participate in management reviews of process performance, product quality and of the quality management system in order to identify and action opportunities for continual improvement. Participates in cross functional teams as the Quality/Qualified Person representative. Reviews and approves Product Quality Reviews Experience/ Skills: Direct experience of GMP management within a pharma/biopharma company is essential, and will include exposure to FDA, HPRA or other authorities of similar standing. Biologics manufacturing experience highly desirable Experience in Sterile Manufacturing and/or Clinical Trials Regulations highly desirable High level technical skills including analytical, auditing, pharmaceutical manufacturing, and regulatory inspection management. Technical writing skills required. Expertise in GxP and global regulatory requirements Excellent training/mentoring experience Excellent oral and written communication skills Competent problem solving, risk assessment and impact analysis abilities. Requirements: QP Qualification with at least 5 years of Quality experience in an EU licensed facility in a relevant functional area. Qualified Person status achieved with min 3-5 years of relevant work experience acting as Qualified Person named on a Manufacturing and Importation Authorisation (MIA/ IMP MIA) Aseptic / Sterile Drug Product manufacturing experience desirable Experience with IMP's (Investigational Medicinal Products) desirable Experience with participation in regulatory inspections, presenting or defending departmental functions in audits or regulatory inspections. Understanding and familiarity with European/ FDA regulatory requirements, guidelines, and expectations. Ability to comprehend technical information related to equipment, processes, and regulatory expectations. Maintain knowledge up to date with respect to the current Good Manufacturing Practices (cGMP), technologies and quality systems for the products they certify We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law. 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.
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. Packaging Technician, Shanbally, Ringaskiddy, Cork Onsite role - 2 Shift 12 Month Contract ROLE Reporting to Packaging Team Lead, the Packaging Technician is responsible for the day to dayoperationof the packaging suite. The Packaging Technician will work in a team environment with an emphasis onsafety and quality and with a commitment to continuous improvement KEY RESPONSIBILITIES Work as part of a team of Packaging Technicians to complete the packaging of Finished Produce for onward distribution. Detailed batch record keeping which is accurate, complete, legible and in accordance with cGMP requirements. Identify issues on the line and alert the Packaging Equipment Technician. Provide support to the Packaging Equipment Technician to help resolve issues on the line as required Carry out transactions on SAP as required. Ensure the Packaging area is Inspection Ready at all times. Participate in Regulatory Inspections Assist with writing, review and revision of packing documentation as necessary (e.g. batch records, standard operation procedure etc) Demonstrate commitment to a high level of safety awareness with the Packaging Operations Team. Proactively support continuous improvement and lead initiatives with the Packaging Suite. Lead and support the investigation and resolutions of process investigations. Maintain an exemplary personal training record. Execute all operations activities in a safe manner and in strict accordance to SOPs, cGMP regulations and Site Quality Standards. EDUCATION AND EXPERIENCE Previous experience in a highly regulated operating environment such as the biologics, pharmaceutical or medical device sectors is desirable though not essential. Previous packaging experience will be considered advantageous. Demonstrated experience (2+ years) of operating in a team environment (professional) is required. Candidates that can demonstrate a keen sense of focus and attention to detail when fulfilling exacting and repetitious tasks will have a distinct advantage. Must be conscientious and possess strong teamwork and interpersonal skills. Strong communication andproblem-solving skills are highly valued. CONTACTS The Packaging Technician will be required to work closely within a cross-functional team including other Packaging Technicians, Packaging Equipment Technicians and representation from Quality, Material Operations (warehouse) and others. 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. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, sexual orientation, national origin, disability status, protected veteran status, or any other characteristic protected by law. 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. Senior Equipment Engineer - Shanbally Ringaskiddy, Cork Onsite Role Biologics Centre of Excellence (CoE), Technical Development Services (TDS) is hiring a highly skilled and experiencedSr. Equipment Engineer to oversee the management and maintenance of laboratory equipment. The ideal candidate will have a strong background in engineering, exceptional problem-solving skills, and a passion for ensuring the accuracy and reliability of lab instruments. Strategic thinking and the ability to align equipment management with the broader goals of the organization are essential. Key Responsibilities: Manage and maintain all laboratory equipment, ensuring optimal performance and adherence to safety standards. Direct and coordinate the completion of equipment asset lifecycle management, including preventive maintenance (PM) services and repair and implement maintenance schedules and protocols for the regular calibration and servicing of equipment. Diagnose and troubleshoot equipment/instrument technical issues, collaborating closely with vendors and service providers for repairs and replacements. Coordinate and/or conduct training sessions for laboratory personnel on the proper use and care of equipment. Maintain detailed records of equipment inventory, maintenance activities, and service histories. Stay informed about the latest advancements in laboratory technology and recommend upgrades as necessary. Ensure compliance with regulatory requirements and industry best practices. Contribute to the strategic planning of laboratory operations, aligning equipment management with the organization's long-term objectives. Adhere to all safety, environmental, security and quality requirements including, but not limited to: Safety & Environmental Management Systems, Quality Management Systems (QMS) regulations, company policies and operating procedures, and other regulatory requirements. Work independently with occasional guidance from manager and lab scientists to evaluate, select and apply standard engineering techniques, procedures, and criteria, using technical judgment in troubleshooting, making minor adaptations and modifications to existing specifications, procedures, and work instructions. Review procedures and CAPEX equipment plans prior to implementation as well as existing ones for failure analysis and potential improvements. Apply standard data analysis practices and techniques to establish root cause for product and process failures or to support the justification for improvements to products and processes. Implement workplace organization and visual controls (5S), standard work practices, and comprehensive training and certification programs. Facilitate or contribute to corrective and preventive actions while supporting the achievement of BiologicsCoE SQDEC standards as well as 5S principles. Qualifications & Skills: Bachelor or Master's degree in Engineering, preferably in Mechanical, Electrical, or Biomedical Engineering. Minimum of 5 years of experience in lab equipment management or a related field. Proven expertise in the maintenance and repair of laboratory instruments. Strong strategic thinking abilities and experience in integrating equipment management with organizational goals. Proficient in the use of Excel, Power Point and Visio software. Familiar with basic Data analytics, statistical methods Proficiency with CMMS &ower BI would be an advantage Demonstrated results through Lean practices and principles. 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. Director/Associate Director, Product Team Lead - Technical Development and Services Shanbally Ringaskiddy, Cork ( Hybrid) Closing Date Thursday 19th June 2025 SUMMARY DESCRIPTION Responsible for Drug Substance technical leadership and oversight of all commercial lifecycle management activities. RESPONSIBILITIES Drug Substance technical leadership and oversight of the product family to ensure visibility, integration and coordination of all technical lifecycle activities. Provide technical and practical expertise and support across modalities for the involved platform focussed on new product development and manufacturing processes Drive process and manufacturing technology activities across the platform product family network, working closely with the manufacturing sites (Internal / External) to improve capability and add value. Drive standardisation activities across the platform product network. Support Process Stewards and Commercial Support by standardising and optimising related technical processes across the network. Supporting submission and implementation strategies with relevant stakeholders (e.g. regulatory approvals, planning). Management and scientific support of product transfers from and manufacturing sites (internal /external). Perform technical feasibility assessments for product transfers in close collaboration with relevant stakeholders. Identify potential risks and creating contingency plans as needed. SCOPE: Key Performance Metrics: Lifecycle management activities delivered on time and budget Successful Health Authority Approvals where applicable EDUCATION Bachelor's degree in Sciences (preferably Biochemical Engineering or Biological Sciences. Master of Science or related PhD. degree preferred. EXPERIENCE Experience in Biopharma Sterile Manufacturing strongly preferred. 10+ years of professional experience in the pharmaceutical industry, including managerial experience. Additional specialist experience is preferred (e.g., pharmaceutical formulation, process development, manufacturing technology) Strong working knowledge of statistics, quality systems and regulatory requirements across multiple health authorities for GMP production of Biologics. Advanced project management experience/skills required including method transfers, and risk assessment. Knowledge of OPEX principles and tools, and knowledge of R&D processes. Exceptional communication skills required, with an ability to interact with and influence individuals and teams at all levels across the organization and global network. Experience collaborating effectively with other functional groups to achieve business objectives. 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.
