Engineer – FUME & CSQ PRD Quality Assurance

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.

The Engineer – Facility, Utilities, HVAC, and Equipment (FUME) & Computer Systems Quality (CSQ) QA is a hybrid role that is responsible for the Quality oversight of FUME and computer systems regarding system development and lifecycle support for development and clinical supply operations across Product Research and Development (PR&D) to ensure compliance with quality systems and cGMP. This role provides technical guidance and leadership with non-conformance investigations, construction, equipment and computer systems design and validation, change control proposals, procedure revisions, GMP drawings, commissioning and qualification, and maintenance.

This position is essential for maintaining GMP compliance and providing support to internal / external audits.

• Contribute Quality expertise from a FUME standpoint to ensure successful execution of capital projects at LTC-N (primarily focused on K360 pilot plant).
• Collaborate with PRD CSQ QA representative(s) to effectively manage CSV workload, ensuring timely and comprehensive delivery of all CSQ work at LTC-N
• Coach and mentor others in aspects of fundamental Quality Engineering and computer system validation support, including process knowledge, problem solving, project management, and documentation design.
• Provide consultation and interpretation of local procedure, Lilly and Global standards, and regulatory expectations.
• Review and approve applicable procedures to ensure compliance with Lilly Quality standards and regulatory requirements. Assess potential gaps between local procedures and Lilly and Global standards and facilitate remediation efforts.
• Influence and oversee the Commissioning and Qualification (C&Q) and Computer System Validation (CSV) of GMP assets including review and approval of associated Engineering/GMP deliverables.
• Influence and oversee GMP drawings including review and approval of GMP drawings
• Evaluate potential product quality impact for any GMP-related incident (Change Control and non-conformance), perform initial leveling, and support the investigations to ensure proper RCA and establishment of effective CAPA to prevent recurrence.
• Escalate/Notification to Management for departure of critical nature and assure issues are addressed appropriately.
• Perform Quality approvals of GMP documents such as Critical Alarm Audits, Utilities Reports, Business Reviews and Periodic Quality Evaluations
• Ensure PR&D is audit ready at all times and participate in internal/external inspections.

• Bachelor’s degree in biochemistry, engineering, pharmacy, or science-related field
• At least 5 years’ experience supporting cGMP manufacturing (QA, TSMS, operations, engineering, auditing, etc.
• Previous experience as a FUME or CSV professional

• Strong knowledge of GMP, FUME processes, and Computer System Validation principles.
• Become/remain certified on CSV (Computer System Validation)
• Excellent communication and documentation skills.
• Ability to work collaboratively in a fast-paced environment.
• Proficient in influencing complaint/deviation/change authors via both verbal and written feedback
• Proven ability to envision and oversee implementation of continuous improvements
• Previous QA experience

• On-site, day shift position located in Indianapolis (LTC-N) with expectation of 3 days per week minimum on-site but flexibility given to the days. After hour support may be required depending on business need.
• Occasional travel (