Sterile Manufacturing Technician

Job description

Who We Are BioMarin is a leading rare disease biotechnology company focused on genetically defined conditions. Guided by our purpose to develop medicines that make a profound impact on people’s lives, our global teams have delivered a portfolio of therapies since our founding in 1997. Our revolutionary treatments for conditions like achondroplasia (the most common form of dwarfism), PKU (phenylketonuria), CLN2, a form of Batten disease, and a number of forms of MPS (mucopolysaccharidosis) offer new possibilities for patients and families who previously had few, if any, available options. More recently, with the close of the Amicus acquisition, our portfolio has expanded to include therapies for Fabry disease and Pompe disease, expanding our ability to reach more people living with rare genetic conditions. Our success comes from our unwavering commitment to excellence, our deep understanding of patient needs, our scientific expertise, and our world-class manufacturing capabilities. At the heart of BioMarin is a dedicated team of the brightest minds in the industry working together to deliver innovative therapies to patients and families around the world. 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. Sterile Manufacturing Technician Onsite - 3 Shft Cycle Closing Date: 26th August 2026 Reporting to the Drug Product Team Lead, 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 role is currently a 3-Shift rotation with potential for future shift work changes as 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. Provide leadership and guidance on shift to support and influence positive behaviour. 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 facility is required . Previous experience of syringe and vial sterile filling and visual inspection 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. Demonstrated leadership skills in preferred. 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. Ireland Safety Responsibility Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training. Ireland Safety Responsibility Support the organisation’s commitment to environmental protection, injury prevention, and continual improvement of EHS management systems. Actively contribute to a safe and environmentally responsible workplace by identifying hazards, reporting incidents and participating in EHS initiatives and training.