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. 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. #J-18808-Ljbffr
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, Procurement for Global Supply Chain & Distributors Global Sourcing and Procurement The Global Sourcing and Procurement (GSP) organization is accountable for driving and delivering Procurement value to support stakeholders’ and organizational strategic objectives. The GSP function delivers value to BioMarin by leading transformational change and implementing industry-leading category strategies that directly support the corporate strategy. The GSP organization leverages market intelligence, subject matter expertise, and business insights in the procurement of goods and services and management of BioMarin’s growing third-party spend of $1B+. Through collaboration with our external suppliers and internal business partners, GSP helps bring innovative new medicines to patients. Role Scope: This Senior Manager must implement industry-leading procurement practices, develop deep and wide relationships with stakeholders, drive innovation and continuous improvement in the ways of working. The successful candidate must be results oriented and drive to measurable outcomes by delivering hard and soft savings, develop appropriate SLA’s/ KPI’s to track performance, and create a multi-year road map of opportunities. Responsibilities: The role is responsible for supporting BioMarin's supply chain operations across the full value chain, including - and not limited to – commercial distributors, comprehensive category management, sourcing and procurement of goods and services, supplier relationship management (SRM), and risk mitigation. This includes developing category strategies by engaging stakeholders, understanding their needs, and developing strategies that align with those needs in an industry-standard manner. Category Management: Develop comprehensive category strategies for warehousing/storage, distribution, transportation, global trade category strategies, and commercial distributors. Drive execution of associated projects and programs to deliver optimized Total Cost of Ownership (TCO) with risk mitigation considerations that provide assurance of supply. Includes stewardship of data integrity in systems including GEP Smart, Coupa, and SAP Ariba (pricing, vendor master, category taxonomy). Sourcing and Contracting: Effectively execute end-to-end sourcing process for services, including supplier evaluation, selection, and end-to-end contract management in line with business needs. Lead complex contract negotiations to achieve BioMarin’s operational and business goals. Complex engagements may require a detailed strategic plan in partnership with the Legal department and functional stakeholders. Supplier Relationship Management: Implement and lead the SRM process, in partnership with key stakeholders, to optimize supplier engagement and attainment of company / functional goals. Maintain an in-depth understanding of supplier capabilities, capacity, and overall financial stability to mitigate risk of business disruption. Skills Required: Demonstrated experience with sourcing and procurement in the supply chain industry, including the regulations associated with supply chain management. Specific knowledge and expertise in sourcing supply chain services, logistics, transportation, and warehousing. Strong skills in category strategy development, negotiation, stakeholder management, and supplier management. Proficient project management skills are required to develop, implement, and maintain category / sourcing plans. Qualifications: Bachelor’s degree in engineering, supply chain, or life sciences; MBA/MS desirable, C.P.M. desirable. 7+ years of strategic procurement experience with extensive knowledge and experience in category management, sourcing, contract negotiations, and supplier management, preferably within logistics and with commercial distributors in the biotech industry. Knowledge of global trade compliance policies and procedures and evolving/existing cross-border trade regulations: This includes demonstrated expertise in managing relationships with commercial distributors to ensure compliance with international trade requirements, as well as optimizing processes for cost efficiency and timely delivery of BioMarin treatments. Familiarity with distributor selection, evaluation, contract negotiations, and performance management is critical to ensuring adherence to regulatory standards and quality expectations while maintaining robust supply chain operations. Familiarity with complex cross-border logistics, customs clearance, and local market regulations in partnership with distributors is essential to achieving seamless product delivery to the patient and/or treatment provider. Experience in biotech / life sciences industry. 3+ years of supply chain logistics experience. Strong leadership and communication skills, including solid interpersonal, analytical and presentation skills. Travel Requirements: Periodic travel will be required to various BioMarin sites and supplier locations. 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. #J-18808-Ljbffr
The Sterile Manufacturing Technician will support the capital project execution, product transfers and operational readiness activities before moving into routine operational support. This facility will contain a state of the art flexible line using isolator technology for filling of vials and syringes and the facility will support both clinical and commercial filling for the majority of the BioMarin biologics product portfolio. Role Summary SUMMARY DESCRIPTION BioMarin has a high-performing, team based organisation, 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 organisational skills. As part of establishing sterile filling operations at the Shanbally facility, this role will play an important part in the start-up of the facility including tasks such as; attend equipment FATs, develop SOPs and batch records, generate training and qualification programmes, support equipment and process validation activities. Once start up is complete, the Sterile Manufacturing Technician will perform recombination and pooling of drug substance; filling line set-up and sterile filling operations, equipment and line changeovers, and sampling in accordance with approved procedures prior to visual inspection activities. This role will also have responsibility for operation of the parts washer and autoclave. Responsibilities also include root cause analysis of equipment and process problems, and implementing effective solutions, including preventive and/or corrective actions. Responsibilities The ideal candidate will be able to demonstrate a proven track record in a quality-focused, operational GMP environment where attention to detail and commitment to the task at hand is key. Previous GMP Sterile Filling experience is required with a strong preference for candidates with isolator vial and syringe filling experience in a start-up environment. Reporting to the Sterile Drug Product Operations Manager, the successful candidate shall work as part of a team of Sterile Filling Technicians to complete both the manufacturing and visual inspection of sterile drug product as per the schedule for onward processing in the packaging facility. The candidate will be required to work closely within a cross-functional team including other Sterile Filling Technicians, Maintenance Technicians, Quality, Material Operations, Supply Chain and others. This role requires flexibility with regards to work schedules. This is initially a day position, with future shift work required: Demonstrate technical knowledge and experience in cleanroom operations incorporating recombination and pooling of Drug substance and aseptic filling in an isolator environment. Perform all operational tasks related to recombination, pooling, sterile filling and visual inspection in accordance with established procedures. Responsible for the writing, updating and execution of Batch Records, SOPs and other GMP Documentation. Complete detailed batch record and GMP documentation entries which are accurate, attributable, complete, legible & clear, original, timely & prompt. Perform environmental monitoring and routine batch sampling per applicable SOPs. Perform housekeeping duties. Maintain an exemplary personal training record. Pro-actively identifies compliance risks and takes appropriate preventative actions. Proactively identify equipment issues and perform root cause analysis, make recommendations and aid in implementation for more complex and reoccurring issues. Proactively lead and support continuous improvement initiatives within the sterile filling facility. Support investigations into Quality events, including reporting production issues, writing reports and implementing CAPAs, etc. as required. Participate in/Lead cross functional team initiatives. Participate & support site inspections by regulatory agencies. Demonstrate commitment to a high level of safety awareness within the sterile filling team. Execute all operations activities in a safe manner and in strict accordance to SOPs, cGMP regulations and site Quality standards. Support Sterile filling equipment commissioning and qualification. Interface with external vendors & service providers. Experience Previous experience in a highly regulated sterile filling operation is required. Previous experience of syringe and vial sterile filling and visual inspection in a start-up environment is highly desirable. A high mechanical aptitude and capability is desired along with technical experience. 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 and problem-solving skills are highly valued. 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. #J-18808-Ljbffr
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. BioMarin 2026 Graduate Programme - Engineering Are you seeking a rewarding career in an end-to-end manufacturing facility in the biopharmaceutical industry? Make it happen at BioMarin in Cork Our graduate programme is a three-year programme, designed to meet your development needs and career aspirations, incorporating your skills, interests and goals. BioMarin are looking to hire graduates to start employment with us in September 2026. This programme is an opportunity to develop skills and gain experience across multiple departments, including: Manufacturing Engineering Technical Development Sciences (TDS) Quality The BioMarin graduate programme provides a hands-on mentored learning environment to encourage development. The 3 year scheme consists of 3 one year rotations across Manufacturing, Engineering and/or Technical Development Sciences and/or Quality. Each placement will provide a variety of challenging, hands on, work experience. We are 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 organizational skills. We are seeking self-driven, ambitious individuals eager to develop their careers in the Biopharmaceutical industry. The Graduate programme will aim to Provide graduates with an understanding of all aspects of an end-to-end biopharmaceutical manufacturing site Develop the Graduates Engineering / Science knowledge Provide the Graduate with the opportunities to apply that knowledge in the solution of a variety of problems Develop technical and managerial Leadership skills Provide opportunities to develop Communication skills Provide exposure to a regulated environment where high Quality and Patient focus along with Health and Safety are foremost Complete works that form part of their CPD programme to Chartered membership of IEI/IChemE as applicable Education And Experience Currently undertaking a third level Degree / Masters in Engineering, graduating in 2026. Proficiency with standard office software applications, including MS Word, Adobe Acrobat, MS Access, MS Excel, MS Power Point expected. We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. #J-18808-Ljbffr
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. Technical Development Senior Scientist / Engineer Commercial Shanbally, Rinaskiddy, Cork - Hybrid role Responsible for technical oversight of a portfolio of biologic Drug Products at external Contract Manufacturing Organizations (CMOs) and internal sites (Cork, Shanbally) including process performance monitoring/optimization, continuous improvement, process robustness and LCM. Ensure that Drug Product manufacturing processes perform as developed and validated while ensuring continuous process improvement through the application of scientific and engineering expertise. Drive technical requirement for pipeline products assisting late phase and PPQ campaign activities between Technical Development group and External Manufacturing network. Ensure readiness of processes for commercialisation. Responsibilities Provide technical oversight for product(s) manufacturing/testing executed at external and internal partners. Act as Technical Development technical representative on process teams. Act as an SME on biologic Drug Product, including technology transfer, process validation, troubleshooting and investigation on specific product(s). Participate in cross-functional teams, as applicable, to troubleshoot and resolve technical issues using root cause analysis tools. Initiate and lead product improvement projects, involving cross-functional teams. Establish and maintain internal / external network relationships around control strategy. Perform statistical data analysis to recognize trends, identify and drive process improvement or minimize product impact. Assist technical and project management leadership during technology transfers. Lead risk assessments in support of product(s) technology transfers to external partners. Identify and lead product and process improvement initiatives to reduce COGM (Cost of Goods Manufactured). Process Development/Optimisation Develop data driven strategies for process development / product characterisation. Develop designs of experiments for execution of lab studies/analytical work with a high level of autonomy. Late Phase Clinical and PPQ Campaign Activities Provide technical input into site selection for late phase to commercial manufacture. Provide technical oversight / assistance of late phase campaign at external and internal partners. Investigations support / leading role depending on type of investigation. Campaign monitoring. Provide on-site support (Person in Plant) to external and internal partners. Assist PPQ Campaign readiness and execution. Identify technical areas to be completed prior to PPQ. Raise and drive change control including justification of changes vs previous campaign. Maintain/update process technical document and product risk register. Ensure stage gate milestones requirement are met. LCM Identify and implement yield improvement and Value Realisation projects for external and internal partners. Maintain oversight of process performance at external and internal partners. Maintain knowledge of entire manufacturing process throughout the lifecycle of product. Lead the development and implementation of Lifecycle Management of Product/Process knowledge. Develop and execute a life cycle improvement plan for product(s) in partnership with external and internal partners. Ensure and maintain an appropriate process control strategy based on critical quality attributes and other attributes as appropriate. Assess changes to input materials and drive material qualification activities from a technical standpoint. Documentation Author, review and approve technical reports including protocol/reports. Review and assess any updates or changes of the Process description documents. Create and maintain a process specific risk register. Review agency annual product reviews. Regulatory Author CMC sections of regulatory dossiers. Support regulatory inspections for process-related aspects of assigned products when necessary. Maintain oversight and reviews process technical changes, reviews their technical feasibility and challenges technical risk. Contribute to registration strategy and support registration activities. Experience A minimum of 5 years’ relevant experience in the biopharmaceutical industry with a strong MSAT and process development experience in Drug Product biologics. Working knowledge of pharmaceutical regulatory requirements appropriate to level and strong knowledge of the cGMP manufacturing process. Ability to collaborate in a global team environment at all levels of the organisation. Ability to start up and lead cross functional teams in the resolution of short-term issues or sustained performance for long-term goals. Strong working knowledge of statistics, quality systems and regulatory requirements across multiple health authorities for GMP production of biologics. Excellent organizational, written and verbal communication and negotiation skills. Experience with Change Control, Deviation, CAPA, FMEA, RCA tools in a highly regulated manufacturing environment. Demonstrated strong leadership and coaching qualities. EDUCATION Minimum B.Sc (M.Sc. or PhD Preferred) degree in relevant scientific discipline e.g. biochemistry, microbiology, biological sciences or related biop. 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. #J-18808-Ljbffr
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. Site Inventory Management Lead - Shanbally, Ringaskiddy (Hybrid role) Closing Date: Friday 4th April 2025 Reporting to the Sr. Manager of Supply Chain Operations, the Shanbally Site Inventory management lead will be responsible for ensuring Raw materials and FG inventory processes & performance are delivering with excellence for manufacturing in Shanbally. This scope for this role is the full site, biologics manufacturing drug substance, drug product (vial and syringe filling) and final packaging across all functions. Responsibilities Owner of the Raw materials and FG inventory management on site – management to agreed entitlement levels Owns and continuously improves the inventory processes. Leads the deployment of best practices and maturing of the site planning processes through the SAP deployment. Responsibility for significant Raw materials inventory and FG inventory levels Enables uninterrupted supply of commercial drug product to our patients globally. Responsible for driving and delivering ATS (Adherence to Schedule) to ensure safety stocks in the Distribution centres meet patient needs Develop stock knowledge in all aspects of BioMarins procurement categories to include raw & finished materials, packaging, consumables, equipment & facilities. Ensure all inventory locations/outlets adequately meet service levels at all times. Ensure inventory levels are adequate for projected sales levels on an ongoing basis. Lead regular inventory management meetings, liaising with all relevant departments to ensure all stock records are accurate. Leads efforts to optimise inventory – maximise service levels for the appropriate inventory levels. Minimises expiry. Guiding make to buys decisions. Writes on and off inventory in SAP in alignment with finance team Ensures counts are executed in all areas and corrections when needed Activates and drives the teams to ensure all agreed processes and procedures are followed so that inventory levels are understood and kept in control Partners & drives the actions with the relevant functions, Finance, SCO team, Manufacturing, 3PL, etc Accountable for upkeep of Internal and externals warehouse & stock locations with regular storage checks. Liaise regularly with vendors, maintaining good professional relationships. Oversee systems that ensure accurate entry of all goods-in, returns, inter-branch transfers and other stock movements. Production of slow-moving stock reports, monitor BBD & effective stock rotation system. Drive continuous improvement in all aspects of inventory management to ensure lean & robust processes, budget control and adequate storage locations. Co-ordinate the stock taking procedures monthly & relevant reports. Point of contact for stock related periodic & annual external auditors. Minimum Requirements Educational B.Sc. in Supply Chain Supply Chain Qualification APICS certification highly desirable. Experience SAP EWM expertise Minimum of 8 years’ hands on supply chain experience 5 years’ experience biopharma or pharma in a complex, virtual, Commercial Supply Chain Environment. Proven track record of effectively managing inventory of at least USD100million in Ireland. Skills A SAP EWM S4 expert that is a strong collaborator with various functions within BioMarin, including purchasing, finance, manufacturing, quality and the warehouse Strong organizational, analytical, and interpersonal skills. Demonstrated ability to work in cross-functional as well as internationally with minimal supervision. Ability to prioritize and manage deadlines in a fast paced, dynamic environment with multiple projects. Business process thinker that drives for continuous improvement of business process to achieve product strategies. Demonstrated, deep understanding of end-to-end global supply chain processes. Excellent communications skills with the ability to work in a global, matrix organization. Strong analytical, organization, decision making, written and verbal communication and presentation skills to operational as executive levels. Comfortable with ambiguity, able to distil key decisions from complex data and environment and effectively articulate issues such that they resonate with senior management. 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. #J-18808-Ljbffr
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. Senior Process Engineer - 12 Month Contract Onsite Role - Shanbally, Ringaskiddy Closing Date: 26th March 2025 We have an exciting opportunity for a Senior Process Engineer to support Drug Product Filling Operations as part of the Process Engineering team onsite at Shanbally. This is a great opportunity for someone to be a part of a site where we are expanding our site capabilities to meet growing demand by qualifying multiple products on our new Drug Product filling line and supporting Drug Product Technology Transfers. Our Shanbally site is growing rapidly across Drug Substance, Drug Product and Packaging, and we are keen on people development and continuously improving our ways of working and always aim for best in class. The Senior Process Engineer reports to the Senior Manager, Process Engineering and is responsible for ensuring process engineering activities are implemented in a compliant manner. Provide process engineering services to Manufacturing in a Biologics Drug Substance, Drug Product Filling, Packaging and Labelling facility. Main Areas of Responsibility: Provision of technical engineering support to Drug Product Filling operations including process performance monitoring, troubleshooting process investigations and process optimisation. Fulfil system ownership responsibilities for assigned Drug Product Filling equipment including production recipe and cleaning recipe updates where required. Provide technical engineering support for process fit to plant workshops to ensure successful technology transfers of new products. Participate in cross-functional project teams to ensure project and site stakeholder inputs and requirements are clear and reflected in design deliverables and support qualifications as required. Lead and participate in cross-functional teams to troubleshoot and resolve technical issues, drive continuous improvement and process optimisation using tools such as DMAIC, SMED and FMEA. Provide coaching and support to the Drug Product Filling Operations and Process Engineering team to build their knowledge. Required to comply with Company Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities. Ensures relevant metrics are in place to effectively monitor and report out on operational performance and identify/implement improvement opportunities quickly. Ensure relevant documentation is prepared and updated in line with all Quality and regulatory guidelines and promotes full compliance to all GMP, environmental and safety requirements. Work collaboratively to drive safe, high quality, and cost-effective manufacturing facilities. Instil the use of Right First Time (six-sigma) and lean manufacturing practices leading to operational excellence. Ensure adherence to high standards of quality and support of a science and risk based quality culture. Ensures that all manufacturing methods and practices are consistent with industry and BioMarin standards. Maintains professional and technical knowledge by attending workshops, reviewing professional publications, establishing professional networks and participating in professional societies. Other duties as assigned. Education and Experience: BSc Degree in Engineering - Process, Chemical, Mechanical or equivalent discipline. Other continuing education initiatives highly desirable - Six Sigma, Lean Manufacturing, industry specific coursework. 5-8 years of leading engineering initiatives in a GMP/GCP compliant environment. Biopharma operations experience required. 3+ years of directly related experience in Filling Operations. Strong knowledge on cGMPs (US & EU), OSHA, ISO, and other regulatory agency standards and requirements applicable to a pharmaceutical production facility. Experience with change control process and implementing change on engineering systems. Demonstrated ability to partner with other functional groups to achieve business objectives required. Superior communication skills – Oral, written and formal presentation skills with senior management, middle management and line staff. Creative problem-solving skills. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. #J-18808-Ljbffr
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. Senior Process Engineer - 12 Month Contract Onsite Role - Shanbally, Ringaskiddy Closing Date: 26th March 2025 We have an exciting opportunity for a Senior Process Engineer to support Drug Product Filling Operations as part of the Process Engineering team onsite at Shanbally. This is a great opportunity for someone to be a part of a site where we are expanding our site capabilities to meet growing demand by qualifying multiple products on our new Drug Product filling line and supporting Drug Product Technology Transfers. Our Shanbally site is growing rapidly across Drug Substance, Drug Product and Packaging, and we are keen on people development and continuously improving our ways of working and always aim for best in class. The Senior Process Engineer reports to the Senior Manager, Process Engineering and is responsible for ensuring process engineering activities are implemented in a compliant manner. Provide process engineering services to Manufacturing in a Biologics Drug Substance, Drug Product Filling, Packaging and Labelling facility. The main areas of responsibility are as follows: Provision of technical engineering support to Drug Product Filling operations including process performance monitoring, troubleshooting process investigations and process optimisation. Fulfil system ownership responsibilities for assigned Drug Product Filling equipment including production recipe and cleaning recipe updates where required. Provide technical engineering support for process fit to plant workshops to ensure successful technology transfers of new products. Participate in cross-functional project teams to ensure project and site stakeholder inputs and requirements are clear and reflected in design deliverables and support qualifications as required. Lead and participate in cross-functional teams to troubleshoot and resolve technical issues, drive continuous improvement and process optimisation using tools such as DMAIC, SMED and FMEA. Provide coaching and support to the Drug Product Filling Operations and Process Engineering team to build their knowledge. Required to comply with Company Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good Manufacturing Practices (cGMP) in the performance of day-to-day activities. Ensures relevant metrics are in place to effectively monitor and report out on operational performance and identify/implement improvement opportunities quickly. Ensure relevant documentation is prepared and updated in line with all Quality and regulatory guidelines and promotes full compliance to all GMP, environmental and safety requirements. Work collaboratively to drive safe, high quality, and cost-effective manufacturing facilities. Instil the use of Right First Time (six-sigma) and lean manufacturing practices leading to operational excellence. Ensure adherence to high standards of quality and support of a science and risk based quality culture. Ensures that all manufacturing methods and practices are consistent with industry and BioMarin standards. Maintains professional and technical knowledge by attending workshops, reviewing professional publications, establishing professional networks and participating in professional societies. Other duties as assigned. Education and Experience: BSc Degree in Engineering - Process, Chemical, Mechanical or equivalent discipline. Other continuing education initiatives highly desirable - Six Sigma, Lean Manufacturing, industry specific coursework. 5-8 years of leading engineering initiatives in a GMP/GCP compliant environment. Biopharma operations experience required. 3+ years of directly related experience in Filling Operations. Strong knowledge on cGMPs (US & EU), OSHA, ISO, and other regulatory agency standards and requirements applicable to a pharmaceutical production facility. Experience with change control process and implementing change on engineering systems. Demonstrated ability to partner with other functional groups to achieve business objectives required. Superior communication skills – Oral, written and formal presentation skills with senior management, middle management and line staff. Creative problem-solving skills. We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law. #J-18808-Ljbffr
Unlock Your Potential with BioMarin! Are you ready to embark on an exciting career journey with a leading-edge biopharmaceutical company? BioMarin is seeking passionate individuals to join our dynamic team in Shanbally, Cork. As an Automation Apprentice, you'll gain hands-on experience, work alongside industry experts, and contribute to groundbreaking advancements in genetic disease treatments. Don't miss this chance to make a real impact and transform lives—apply now and be part of something extraordinary! Automation Apprentice - Shanbally, Ringaskiddy, Cork Closing Date - 15th April 2025 This 3-year program, which will commence in Autumn 2025, combines workplace learning onsite with BioMarin in Shanbally, Ringaskiddy, with academic studies at Munster Technological University (MTU), leading to a Level 7 Bachelor of Engineering in Manufacturing Engineering. This is an exciting opportunity to be part of the BioMarin Automation team and work in a fast-paced, collaborative, and supportive environment where learning, growth, and development are endless. Throughout your apprenticeship, a senior member of the Automation and MES team will be your mentor, providing guidance and development opportunities throughout your journey with BioMarin. This apprenticeship was designed with close alignment to the current needs of the Irish manufacturing industry, therefore providing invaluable experience to the apprentice and increasing BioMarin’s pipeline of STEM2D (Science, Technology, Engineering, Maths, Manufacturing, and Design) talent. On successful completion, the Automation Apprentice will be awarded a Bachelor of Engineering in Manufacturing Engineering (Apprenticeship), Level 7. Who can apply? Applicants that have achieved at least Grade 06 in 5 Leaving Certificate subjects, including Mathematics, English, and preferably one Technical/Science subject with a minimum of 250 CAO points is required. Applications are also open to those completing their Leaving Certificate in June 2025. Key Responsibilities The Automation Apprentice will report to a Senior Member of Automation & MES during your 3-year apprenticeship and will participate in facility commissioning, start-up, and support Automation Operations associated with Production Processes, Facilities, and Utilities systems. 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 coordinate the worldwide movement of our drugs to patients. Learn to provide technical support of existing control systems utilized in Manufacturing and Facilities operations. Learn to lead/executing the design, engineering, and commissioning of new control systems. Learn to provide Technical support to the Engineering Department on the specification of control systems for new Equipment. Learn to support Daily Operations for Automated Systems and ensure cGMP requirements are met. Learn to prepare SOPs, Functional Specifications, Detailed Design Specifications, and other documents required for a cGMP Automated environment. Participate in quality investigations and perform Automation execution of Change Controls. Develop and review training materials. Other duties as assigned. What awaits you at BioMarin? This is a fantastic opportunity to work with a leading-edge Biopharmaceutical company that, through focusing on genetic diseases, gives its employees the opportunity to truly impact and transform patients’ lives. Over two decades ago when we first opened our doors, we focused on giving much-needed attention to the underserved communities of those with rare diseases. These rare disease communities mostly affected children and were often ignored. At the time, BioMarin developed the only treatments for these life-altering conditions, giving hope to patients and families. Competitive salary with annual increases (Earn while you learn!) Annual bonus Onsite gym Free car parking Subsidised canteen 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. #J-18808-Ljbffr
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 - Drug Product Technology Transfer - Cork/Dublin/Remote Closing date: January 23, 2024 Technical Development Services (TDS) are hiring for a Director of Drug Product Technology Transfer (Sterile) with the following remit. Provide technical and scientific leadership to the Drug Product Internal and External manufacturing network through partnerships with global functions and third-party Commercial Manufacturing Organisation’s (CMOs) to introduce new products and technologies. Provide technical leadership in onboarding new commercial assets across all modalities and ensure their successful integration into the BioMarin Operating Model. Accountable for the project execution and delivery of successful process characterisation, engineering, process performance and support to regulatory filing for drug product. Driving excellence in Tech Transfer execution for Sterile Drug Product. Project Portfolio Ownership. Drug Product Technology Transfer and Product LCM team are responsible for: Being the primary interface between GEO Manufacturing Operations, Internal Drug Product manufacturing and TDS for Technology Transfer and LCM. The delivery of Technology Transfer across the Global External Operations and internal Manufacturing Network and successful handover to operations team. Development and implementation of Tech Transfer best practices and standardisation across the Internal and external manufacturing network. Supporting the development and execution of the Network Operations Strategy through Tech Transfer. Successful delivery of the product development pipeline and commercialisation strategy. Duties: Leadership: Lead a team of scientists and engineers in the delivery of TT for Drug Product across our Global Manufacturing Network. Manage and communicate the project portfolio to key stakeholders. Identify, recruit, develop and retain qualified individuals to lead Tech Transfer. Experienced in authoring, reviewing, and coaching of staff in regulatory filing submissions. Create and maintain an environment of teamwork and collaboration while developing and motivating a high performing team that models the organisation values and attributes. Serve as an influential member of the Drug Product and Packaging Development leadership team, who impacts decision making and takes an active role in promoting initiatives, teamwork, and collaboration across functions. Partner with Drug Product and Packaging Development leadership to provide technical expertise and discussion during GMP audits from regulatory authorities. Ensure personal understanding of all quality policy/BioMarin system items that are per training curriculums. Participate in cross-functional teams, as applicable, to troubleshoot and resolve technical issues using root cause analysis tools. Participate in Global Partner Teams and CMC team as required. Skills: Experience in the Biopharma, experience in Process Development and MSAT/ Technical Development organizations is desirable. 10+ years of professional experience in the pharmaceutical industry, including managerial experience. Demonstrated to lead and develop an effective team of scientists and engineers. A broad understanding of Drug Product and a keen sense of business acumen. Experience collaborating effectively with other functional groups to achieve business objectives. Effective decision-making skills – ability to negotiate and balance decisions and priorities across needs of multiple stakeholders. Demonstrated initiative; results oriented, initiative to institute change. 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 with CAPA, FMEA, RCA tools in a highly regulated manufacturing environment. Education: Degree in Engineering, Science or Business Discipline. PhD / master’s in science or engineering Discipline is preferable. Location: Ireland - Cork/Dublin/Remote Travel: 15-25% 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. #J-18808-Ljbffr
