Sr. Principal Engineer - Bioprocess

About the Company

At Lilly, we unite caring with discovery to help make life better for people around the world. Headquartered in Indianapolis, Indiana, our over 50,000 employees tackle complex challenges to discover and deliver life-changing medicines, strengthen health understanding and management, and support the communities we serve. We are constructing an advanced manufacturing facility in Goochland County, Virginia, for monoclonal antibodies, bioconjugates, and aseptic drug product manufacturing to provide capacity for current and future products.

Responsibilities

• Facility Start-Up Phase:
  • Provide Process Engineering support to the Global Facility Delivery team with a 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).
  • 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 a core member of a cross-functional process team.
  • Utilize root cause analysis techniques to investigate process and equipment issues and deliver robust, 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.

Requirements

• Bachelor's Degree in Process, Chemical, Biochemical Engineering, or a related applicable discipline.
• 7+ years of process team experience in pharmaceutical manufacturing, preferably monoclonal antibody manufacturing.
• Must be 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.

Preferred Qualifications

• Deep technical interest and understanding in monoclonal antibody manufacturing and Bioprocess Engineering.
• Strong analytical and problem-solving skills.
• Ability to work independently and as part of a diverse Process Team (management, production, science, quality, and engineering professionals).
• Creativity to identify improvement opportunities and the tenacity/initiative to implement them.
• Experience guiding/mentoring others through processes.
• Flexibility to meet business needs.

Benefits

• Eligibility to participate in a company-sponsored 401(k) and pension plan.
• Vacation benefits.
• Medical, dental, vision, and prescription drug benefits.
• Flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts).
• Life insurance and death benefits.
• Certain time off and leave of absence benefits.
• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).
• Company bonus (depending on company and individual performance).

Pay

The anticipated wage for this position is $79,500 - $171,600.