Senior Fill Finish Process Engineer
Biogen · Athlone
About This Role
The Senior Fill Finish Process Engineer is a site-based member of the Global Engineering & Facilities within the Drug Product Engineering Technical Authority. The role provides technical leadership for aseptic fill-finish and sterile drug-product manufacturing systems, with accountability spanning facility-fit assessments, feasibility studies, front-end capital planning, engineering design, project execution and operational readiness.
As the primary GEF interface at the Athlone site, the position connects site stakeholders with Biogen’s Global Engineering Technical Authorities and coordinates the appropriate discipline support for capital projects, technical assessments and operational priorities. The engineer applies lifecycle-based engineering practices to ensure that facilities, equipment and systems are safe, compliant, reliable, scalable and aligned with Biogen standards and long-term manufacturing strategy.
What You'll Do
Aseptic Manufacturing & Drug Product Engineering
- Serve as a Subject Matter Expert (SME) for aseptic filling, sterile manufacturing processes, isolators, RABS, lyophilization, autoloading systems, and associated drug product technologies.
- Provide engineering leadership and technical guidance for drug product manufacturing systems throughout their lifecycle.
- Support technical due diligence, process evaluations, and manufacturing network assessments.
- Partner with site engineering and operations teams to identify opportunities for process improvements, capacity expansion, and technology deployment.
Facility Fit & Feasibility Studies
- Lead Facility Fit Assessments for new products, technologies, and manufacturing opportunities.
- Develop and execute feasibility studies for facility modifications, capacity expansion projects, and new manufacturing investments.
- Evaluate process, equipment, utility, infrastructure, automation, and facility requirements to support informed project decisions.
- Support business case development and capital planning activities.
Capital Projects & Engineering Design
- Support the development and execution of capital projects from concept through operational readiness.
- Collaborate with Engineering & Architectural (A&E) firms during feasibility, conceptual design, FEED, detailed design, and construction activities.
- Review engineering deliverables including layouts, process flow diagrams, equipment specifications, utility assessments, and design packages.
- Ensure projects align with Biogen engineering standards, GMP requirements, and long-term technical strategies.
- Provide technical leadership during project reviews, design workshops, and stage-gate governance activities.
Site Technical Authority Representation
- Act as the on-site representative for Global Engineering & Facilities.
- Provide local coordination and support for Drug Product, Facilities, Automation, and other Technical Authority functions as required.
- Facilitate communication and alignment between global technical authorities and site stakeholders.
- Support engineering investigations, technical assessments, and site operational issues as required.
New Opportunities
- Support assessments of other future modalities as required - finished goods, packaging, assembly, labeling, and related manufacturing opportunities.
- Participate in strategic evaluations for future facility expansions and capability development.
- Provide engineering support for technology transfers and implementation of new manufacturing platforms.
Technology & Innovation
- Monitor industry trends, emerging technologies, and best practices in aseptic processing and pharmaceutical manufacturing.
- Support development and deployment of engineering standards, specifications, and best practices.
- Partner with vendors, equipment suppliers, and industry experts to identify innovative technical solutions.
- Drive continuous improvement and engineering excellence across the manufacturing network.
Who You Are
You are a highly capable engineering professional with strong experience in sterile pharmaceutical manufacturing, facility design, and capital project execution. You apply sound engineering judgement to complex and sometimes ambiguous problems, translate technical risks into practical recommendations, and influence decisions across site, global and external stakeholders
You are comfortable influencing stakeholders across all organizational levels and can effectively represent Global Engineering & Facilities within a manufacturing site environment.
Required Qualifications
- Bachelor's degree in Mechanical, Chemical, Industrial, Pharmaceutical, or related Engineering discipline.
- Engineering experience within the pharmaceutical, biotechnology, medical device, or related regulated manufacturing industries.
- Experience supporting aseptic manufacturing operations and sterile processing technologies.
- Experience with facility fit assessments, engineering evaluations, and feasibility studies.
- Experience supporting capital projects and facility modifications.
- Working knowledge of GMP requirements and pharmaceutical facility design principles.
- Strong communication, technical writing, and presentation skills.
- Demonstrated ability to influence cross-functional teams and senior stakeholders.
Preferred Qualifications
- Experience within an Engineering & Architectural (A&E) consulting firm.
- Experience supporting fill-finish manufacturing facilities and sterile product operations.
- Knowledge of isolator technology, RABS, lyophilization, material transfer systems, Automated Visual Inspection systems and contamination control strategies.
- Experience with Front-End Engineering Design (FEED), conceptual design, and detailed design activities.
- Experience supporting packaging, finished goods, or secondary manufacturing operations.
- Master's degree in Engineering or related discipline.
- Professional Engineering (PE) registration or equivalent engineering certification.
Why Biogen?
We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.
At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired. Read on to learn more about Biogen.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
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