Sr. Engineer II, Mfg Sciences (Parenteral Filling)

Biogen-posted 3 days ago
$109,000 - $146,000/Yr
Full-time • Mid Level
Onsite • Durham, NC
5,001-10,000 employees
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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 towards improved facility capabilities, efficient systems, improved technical competency, or increased process/scale-up understanding.
  • Cultivate continuous improvement environment within the process transfer teams at the RTP site and benchmark tech transfer best practices both internal and external to Biogen, as appropriate.
  • Be the Subject Matter Expert to support inspections and audits.
  • Lead process investigations while servicing as the point of contact to broader organization.
  • Perform data analysis to support process improvements or process transfers.
  • Manage technical projects providing value to the Pharma site.
  • Facilitate meetings with various stakeholders and communicate to management on the status of programs.
  • Bachelors degree in Engineering or relevant scientific/technical discipline with at minimum 6 years of relevant experience is required OR Masters degree in Engineering or relevant scientific/technical discipline with at minimum 4 years of direct experience OR Ph.D. in Engineering or relevant scientific/technical discipline with at minimum 2 years of direct experience
  • Good communication and project management skills appropriate for leadership of tech transfer projects.
  • In-depth knowledge in technical understanding of Parenteral Filling Operations (e.g. Filling Isolator, Lyophilizer, Visual Inspection) including transfer of such processes into full-scale drug product manufacturing facilities.
  • Excel at working in a team environment
  • Comfortable analyzing scientific datasets/analytical skills with excellent written skills
  • Ability to work independently and support a large cross-functional group
  • Knowledge of cGMP, FDA/EMA regulations, Process Performance Qualification, Continued Process Verification
  • Ability to work weekends and be on call.
  • Medical, Dental, Vision, & Life insurances
  • Fitness & Wellness programs including a fitness reimbursement
  • Short- and Long-Term Disability insurance
  • A minimum of 15 days of paid vacation and an additional 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) program participation with company matched contributions
  • Employee stock purchase plan
  • Tuition reimbursement of up to $10,000 per calendar year
  • Employee Resource Groups participation
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