Senior Aseptic Fill-Finish Process Lead

Biogen, Inc.; Athlone; Vor Ort; EUR 90.000 - 120.000; Vollzeit

Zusammenfassung

Biogen is seeking a Senior Fill Finish Process Engineer in Athlone to lead aseptic manufacturing initiatives and capital projects within Global Engineering & Facilities. You will guide sterile processing technologies, conduct feasibility studies, and ensure alignment with GMP and Biogen standards across the manufacturing lifecycle.

The role requires substantial experience in sterile pharmaceutical operations, facility assessments, and cross-functional leadership to advance new products and

Qualifikationen

• Bachelor's degree in Mechanical, Chemical, Industrial, Pharmaceutical, or related Engineering discipline.
• Experience in 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.

Aufgaben

• Serve as SME for aseptic filling, sterile manufacturing processes, isolators, RABS, lyophilization, autoloading systems, and related 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.
• 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.
• Support business case development and capital planning activities.
• Support the development and execution of capital projects from concept through operational readiness.
• Collaborate with Engineering & Architectural firms during feasibility, conceptual design, FEED, detailed design, and construction.
• Review engineering deliverables and ensure alignment with Biogen standards and GMP.
• Provide technical leadership during project reviews, design workshops, and governance.

Ausbildung

Bachelor's degree in Mechanical, Chemical, Industrial, Pharmaceutical, or related Engineering discipline

Jobbeschreibung

Biogen is seeking a Senior Fill Finish Process Engineer in Athlone to lead aseptic manufacturing initiatives and capital projects within Global Engineering & Facilities. You will guide sterile processing technologies, conduct feasibility studies, and ensure alignment with GMP and Biogen standards across the manufacturing lifecycle.

The role requires substantial experience in sterile pharmaceutical operations, facility assessments, and cross-functional leadership to advance new products and