Sr. Principal Engineer - Bioprocess

Role Summary

Sr. Principal Bioprocess Engineer to support Lilly’s new manufacturing facility in Goochland County, Virginia, focused on startup and ongoing GMP manufacturing operations for monoclonal antibodies, bioconjugates, and aseptic drug product manufacturing. This role is part of the leadership team for the site startup and will help build the organization, facility, and culture to enable a successful startup into GMP manufacturing operations. Location: Goochland County, Virginia.

Responsibilities

• Facility Start-Up Phase; Provide Process Engineering support to the Global Facility Delivery team (Lilly’s Global Large Scale Capital Delivery Team) with a strong focus on right first time and on schedule facility start-up (e.g., design reviews, process safety assessments, User Requirements, C&Q support, Unit Operation Shakedown, Facility Run Rate Readiness).
• Define and own relevant aspects of the overall integrated Operational Readiness Plan (e.g., SOP development, maintenance strategy, automation optimization, run rate readiness, MES EBR requirements, alarm requirements, Performance Qualification Study Requirements / Protocol Development, etc.).
• Own the Performance Qualification strategy and execution for area of responsibility.
• Support initial Operations Training requirements as the Equipment and Area SME.
• Lead/support the tech transfer of new processes into the facility.
• Post facility start-up phase; Provide process engineering support through application of process engineering fundamentals.
• Identify and implement continuous improvement opportunities related to equipment and processes as core member of cross-functional process team.
• Utilise root cause analysis techniques to investigate process and equipment issues and deliver robust and sustainable corrective and preventative actions.
• Monitor, assess and document equipment performance to maintain ongoing qualification.
• Develop and maintain the basis of safety for process equipment.
• Develop and implement unit operation and equipment control strategy.

Qualifications

• Required: Bachelor's Degree in Process, Chemical, Biochemical Engineering or related applicable discipline
• Required: 7+ years of process team experience in pharmaceutical manufacturing, preferably monoclonal antibody manufacturing
• Required: Authorized to work in the United States on a full-time basis; Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1
• Preferred: Deep technical interest and understanding in the field of monoclonal antibody manufacturing and Bioprocess Engineering.
• Preferred: Strong analytical and problem-solving skills.
• Preferred: Ability to work on own initiative and as part of a Process Team consisting of a diverse group of management, production, science and engineering professionals.
• Preferred: Creativity to identify improvement opportunities and the tenacity/initiative to see them implemented.
• Preferred: Guidance/mentoring of others through processes.
• Preferred: Flexibility to meet business needs.