Sr. Engineer II, Mfg Sciences; Parenteral Filling

About This Role

As a member of Manufacturing Sciences within the Parenteral Filling area, the Sr. Engineer II will provide technical expertise to the clinical and commercial manufacturing campaigns run at the Pharma Site. The focus of this position will be as a key leader for investigations and project implementation for Manufacturing Sciences using their technical expertise on fill/finish, visual inspection, and packaging.

• Provide technical expertise to the clinical stage, PPQ, and commercial manufacturing campaigns run at the site.
• Lead Process & Technology Transfer teams, technical improvement projects, and technical process investigations as needed.
• Provide technical and operational guidance to Manufacturing during GMP campaigns.
• Lead technical investigations towards process impact assessments and ensure timely completion and communication.
• Author Manufacturing and Process Performance Qualification validation protocols and technical reports.
• Lead small teams on technical projects toward improved facility capabilities, efficient systems, improved technical competency, or increased process/scale‑up understanding; cultivate continuous improvement within transfer teams.
• Be the Subject Matter Expert to support inspections and audits.
• Lead process investigations while serving as the point of contact to the broader organization.
• Perform data analysis to support process improvements or transfers; manage technical projects providing value to the Pharma site.
• Facilitate meetings with stakeholders and communicate program status to management.

You are a proactive and detail‑oriented individual who thrives in a collaborative team environment. Your communication skills help you effectively lead technical projects and engage with cross‑functional groups. You have a strong analytical mindset and are comfortable working with scientific datasets. Your independence and ability to manage multiple priorities make you an asset to the organization.

• Bachelor’s degree in Engineering or relevant scientific/technical discipline with at least 6 years of relevant experience.
• Master’s degree in Engineering or relevant scientific/technical discipline with at least 4 years of direct experience.
• Ph.D. in Engineering or relevant scientific/technical discipline with at least 2 years of direct experience.
• Good communication and project management skills appropriate for leadership of tech transfer projects.
• In‑depth knowledge of Parenteral Filling Operations (e.g., Filling Isolator, Lyophilizer, Visual Inspection) and transfer of such processes into full‑scale drug product manufacturing facilities.
• Excellent teamwork, analytical, and written communication skills.
• Ability to work independently and support a large cross‑functional group.
• Knowledge of cGMP, FDA/EMA regulations, Process Performance Qualification, and Continued Process Verification.
• Availability to work weekends and be on call.

• Medical, Dental, Vision, & Life insurance.
• Fitness & Wellness programs with reimbursement.
• Short‑ and Long‑Term Disability insurance.
• Minimum 15 days of paid vacation plus end‑of‑year shutdown time off (Dec 26‑Dec 31).
• Up to 12 company paid holidays + 3 paid days off for personal significance.
• 80 hours of sick time per calendar year.
• Paid Maternity and Parental Leave benefit.
• 401(k) plan with company match.
• Employee Stock Purchase Plan.
• Tuition reimbursement up to $10,000 per year.
• Employee Resource Group participation.

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.