Sr. Principal Engineer - Bioprocess

BioSpace; Richmond (VA); On-site; USD 120,000 - 180,000; Full time

Job summary

Lilly is constructing an advanced manufacturing facility in Goochland County, Virginia for monoclonal antibodies, bioconjugates, and aseptic drug product manufacturing. We seek a Sr.

Principal Bioprocess Engineer to lead process engineering during startup and throughout ongoing operations, ensuring right-first-time design reviews, qualification, and cross-functional collaboration. The role emphasizes ownership of the Qualification strategy, tech transfer, and continuous improvement in a GMP

Qualifications

• Bachelor's degree in Process, Chemical, Biochemical Engineering or related discipline required.
• 7+ years of process team experience in pharmaceutical manufacturing, preferably monoclonal antibody manufacturing.
• Authorized to work in the United States on a full-time basis; visa sponsorship not provided.

Responsibilities

• Support facility start-up in Goochland County, VA with a focus on right first time and on-schedule startup.
• Own the Performance Qualification strategy and execution for area of responsibility.
• Lead the tech transfer of new processes into the facility and provide training to operations.
• Identify and implement continuous improvement opportunities for equipment and processes.
• Apply root cause analysis to investigate process and equipment issues and drive corrective actions.

Skills

Bioprocess engineering

Pharmaceutical manufacturing

Monoclonal antibody manufacturing

Process safety assessments

Cross-functional collaboration

Problem solving

Education

Bachelor's Degree in Process/ Chemical/ Biochemical Engineering

Tools

MES

Automation systems

Job description

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

Lilly is currently constructing an advanced manufacturing facility for monoclonal antibodies, bioconjugates, and aseptic drug product manufacturing in Goochland County, Virginia. This facility is intended to provide capacity for current and future products. The successful candidate will help to build the organization, the facility and the culture to enable a successful startup into GMP manufacturing operations.

Responsibilities

We are seeking a Sr. Principal Bioprocess Engineer to support our new Manufacturing Facility in Goochland County, Virginia. Process Engineering is core to delivering a right first-time facility start up and continued support of ongoing manufacturing operations into the future.

Some key responsibilities of the role include:

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

Basic Qualifications

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

Additional Preferences

• Deep technical interest and understanding in the field of monoclonal antibody manufacturing and Bioprocess Engineering.
• Strong analytical and problem-solving skills.
• Ability to work on own initiative and as part of a Process Team consisting of a diverse group of management, production, science, quality and engineering professionals.
• Creativity to identify improvement opportunities and the tenacity/initiative to see them implemented.
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