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.

Senior Engineer MSAT
 Come join our team and make a meaningful impact on patients’ lives. MSAT are now building a Centre of Excellence (COE) for Drug Product and are hiring a Principal Engineer/Sr Engineer with the following duties:

Duties

• Support aseptic filling (and lyophilization) operations from early-stage development through Drug Product commercialization and life cycle management.
• Author technical reports to support Drug Product Technology Transfer and Drug Product Process and Product Characterization.
• Support the commercial operations of BioMarin’s existing commercial product portfolio as the MSAT representative on Global External Operations (GEO) Process Team. Perform technical assessments for commercial product deviations for timely closure. Support assessments for product complaints as necessary.
• Represent as the technical SME for Drug Product filling operations and build strong partnerships within the BioMarin Network and externally with our CMO partners in a matrix team environment.
• Support technical delivery of NPI and TT projects through close collaboration internally with cross functional project teams and externally with CMO’s, ensuring compliance with specifications, regulatory guidelines, and right first-time delivery.
• Own Change Control, Deviations, and CAPAs through the quality management system as needed.
• Support on-site implementation of changes and Drug Product launch activities at CMOs.
• Support investigations, facilitate root cause analysis for deviation resolution, data gathering/analysis, and provide technical recommendations for batch disposition as needed.
• Understanding and demonstrated knowledge of regulatory requirements, guidelines, author CMC sections of US and international regulatory documentation, draft responses to the heath agency requests during health agency review.
• Support development of Drug Product global technical policies, standards, and guidelines as needed.
• Identify and lead product and process improvement initiatives that deliver value and improve process reliability.
• Work with and travel to CMO’s to jointly identify opportunities to strengthen our Strategic Partnership.

• Ensure personal understanding of all quality policy/BioMarin system items that are per training curriculums.
• Other duties as assigned.
• Travel as needed (up to 15%).

Skills

• Relevant experience in biotech/pharmaceutical field and served as a Senior Engineer.
• Strong understanding and hands on experience in MSAT or process development or technology transfer, sound background in large scale processing of biologic drug products.
• Proficient in technical writing is needed.
• Experience in authoring module 3 CTD sections to support regulatory filings.
• Team player with demonstrated skills of building strong partnerships and working with diverse team members in a dynamic environment.
• Excellent organizational, interpersonal communication, and problem-solving skills.
• Ability to find, communicate, and implement ways to continuously improve processes.
• Ability to multi-task and manage tight timelines in a fast paced environment.
• Efficient project management and influencing skills.
• Excellent written, verbal, and presentation communication skills.
• Demonstrated strong analytical skills and judgment.
• Effective decision-making skills – ability to negotiate and balance decisions and priorities across needs of multiple stakeholders.
• Proficient in MS Office: Word, Excel, Outlook, PowerPoint, MS Project etc.

Education

• Degree in Engineering, or a relevant Science Discipline and appropriate years of experience is required.
• 6 to 8 years of experience in Drug product manufacturing sciences with hands on experience in a fill finish facility in a technical role (Bachelor’s degree with 8 years, or a Master’s degree with 6 years prior experience).

This role can be based in Cork or Dublin

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.