Senior Principal/Principal Bioprocess Engineer

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

Lilly has just completed construction on a Next Generation Biotech Drug Substance Manufacturing Facility in Limerick, Ireland and we are preparing to expand these facilities.   These facilities will be Lilly’s most technically advanced manufacturing site and include next generation manufacturing technologies and advanced data collection and analysis platforms that will deliver improvements in safety and quality, and increased productivity and process performance. 

Main Purpose and Objectives of Position: 

We are seeking talented and experienced bioprocess engineering professionals for multiple roles to support the expansion of the manufacturing facilities at the Limerick site.  The role will provide engineering subject matter expertise to support the design, construction and preparation for the successful startup of the expanded manufacturing facilities.  The successful candidate(s) will leverage existing engineering design and ongoing start up facility learnings to ensure an enhanced expanded facility start up.  The available positions range from Bioprocess Engineer to Principal Bioprocess Engineer.  The role and responsibility level will be commensurate with candidate experience and qualification. 

Key Duties and 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.).

• Review and support Performance Qualification strategy and execution for area of responsibility.

• Support initial Operations Training requirements as the Equipment and Area Subject Matter Expert (SME).

• Lead/support the tech transfer of new processes into the facility.

• Work with design and project engineers for the design review and verification activities.

• Support the alignment and lessons learned review between the first facility start up in Limerick and the expanded facility from design to operation start up including automation unit operations testing.

Post Expansion 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.

• Utilize 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 Requirements:

• Bachelor’s, Master’s, or Ph.D. degree in Process / Chemical Engineering, Bioprocess / Biochemical Engineering, or a related field.

• Proven experience in bioprocess engineering, with expertise in upstream and downstream processing.

Additional Preferences:

• Deep technical interest and understanding in Large Molecule 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.

• Collaborative skills with operations, automation and other process engineers.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

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