Pharmaceutical Manufacturing Process Engineer

About the position

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. CT Parenteral Operations consists of a vial filling operation and a flex filling operation that both support early phase clinical trials. This process engineer position will support CT Parenteral Manufacturing in B358. This position will report to the CT Parenteral Ops Process Engineering Lead.

Responsibilities

• Provide technical and engineering support during the definition of process and equipment systems requirements, development of systems design and procurement packages, equipment and systems fabrication, installation, startup, testing, commissioning and qualification (C&Q) of the CT parenteral facility project.
• Provide technical oversight and ownership for assigned aseptic processes equipment systems.
• Assure that project process designs/installations are safe, operable, maintainable, economical, and compliant with regulatory requirements.
• Participate in or lead the startup, C&Q activities through Planning, Reviews, Approvals, Execution and/or consultation on activities as needed.
• Provide technical and process engineering oversight for filling equipment and auxiliary systems.
• Maintain current and accurate as-built equipment drawings and records.
• Ensure a safe working environment by following safety rules and helping implement/improve the safety culture.
• Review and support approval of processing tickets and batch records.
• Respond to and implement customer requests related to equipment performance, breakdowns, and improvements.
• Coach and mentor peers in the process engineering team.
• Support peer review documentation of learning points, technical studies and investigations.
• Capture and share lessons learned.
• As Process Equipment and Systems Owner, ensure systems perform in a reliable and efficient manner.
• Schedule and support shutdown maintenance activities with multi-discipline resources.
• Oversee the timely execution of Periodic Qualification Evaluation (PQE) and closure of identified issues.
• Analyze historical data to identify potential areas for improvement.
• Participate in or lead Process Failure Mode and Effect Analysis (pFMEA) and Process Hazard Reviews.
• Utilize change management system to create, review, approve, execute, close changes and associated action items.
• Utilize incident management system to support or lead to create, document, close investigations and associated action items.

Requirements

• BS in Engineering such as Chemical, Mechanical, Industrial, or equivalent.
• Minimum of 3 years relevant experience.
• Exceptional project management, planning, coordination, leading multi-discipline cross functional teams.
• Strong troubleshooting and problem-solving skills.
• Excellent verbal and written communications skills.

Nice-to-haves

• Parenteral Manufacturing experience.
• Experience with equipment C&Q and validation activities preferred.
• Familiarity with Six Sigma or similar process improvement methodologies.
• Familiarity with Trackwise1000.
• Familiarity with GMARS / Maximo or similar maintenance management systems.

Benefits

• 401(k) plan
• Pension
• 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
• Time off and leave of absence benefits
• Well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities)