Senior Fill Finish Process Engineer

About the 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, covering 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 engineer connects site stakeholders with Biogen's Global Engineering Technical Authorities and coordinates discipline support for capital projects and technical assessments.

Key responsibilities

• Serve as Subject Matter Expert for aseptic filling, sterile manufacturing, isolators, RABS, lyophilization and autoloading systems, and guide drug product manufacturing systems through their lifecycle.
• Lead facility fit assessments and feasibility studies for new products, facility modifications and capacity expansion, and support business case and capital planning.
• Support capital projects from concept through operational readiness, working with A&E firms on feasibility, conceptual design, FEED, detailed design and construction, and reviewing layouts, process flow diagrams and equipment specifications.
• Act as the on-site representative for Global Engineering & Facilities and coordinate Drug Product, Facilities, Automation and other Technical Authority functions.
• Support technology transfers, future modality assessments (finished goods, packaging, assembly, labeling) and strategic facility expansion evaluations.
• Monitor industry trends, help develop engineering standards and specifications, and partner with vendors and suppliers on innovative solutions.

Required profile

• Bachelor's degree in Mechanical, Chemical, Industrial, Pharmaceutical or related engineering.
• Engineering experience in pharmaceutical, biotechnology, medical device or regulated manufacturing.
• Experience with aseptic manufacturing, facility fit assessments, feasibility studies and capital projects.
• Working knowledge of GMP requirements and pharmaceutical facility design principles.
• Strong communication, technical writing and presentation skills, and ability to influence cross-functional teams and senior stakeholders.

Preferred qualifications

• A&E consulting experience, FEED and detailed design experience, and knowledge of isolators, RABS, lyophilization, material transfer systems and automated visual inspection.
• Master's degree in engineering or PE registration.