PRD QA 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.

Organization Overview :

Product Research and Development (PRD) Quality Assurance (QA) is responsible for providing quality oversight of all materials used in clinical trials.

The PRD QA Engineer is responsible for oversight of Facilities, Utilities, Maintenance, and Equipment (FUME) and computer systems (CSQ) within PRD and assures compliance with quality systems and current Good Manufacturing Practices (cGMP).

This oversight includes supporting biologic drug substance, parenteral drug product, and distribution facilities.

Responsibilities :

The PRD QA Engineer provides technical guidance and leadership in a variety of interactions with business and operations personnel.

More specific examples include :

• Provide consultation and interpretation of local procedures, corporate standards, and regulatory expectations.
• Review and approve applicable procedures to ensure compliance with corporate standards and regulatory requirements.
• Assess potential gaps between local procedures and corporate standards and facilitate remediation efforts.
• Influence and oversee Commissioning and Qualification (C&Q) and Computer Systems Validation (CSV) of GMP assets including review and approval of associated deliverables (protocols, drawings, test documents, etc.).
• Influence and oversee Maintenance / Calibration programs within PRD, including benchmarking with other Lilly sites.
• Evaluate potential product quality impact for any GMP-related incident (deviation or change control), perform initial assessment, and support the investigations to ensure proper root cause analysis (RCA) and establishment of effective corrective and preventive actions (CAPA).
• Escalate and / or initiate notification to management for departures of critical nature and assure issues are addressed appropriately.
• Ensure PRD is audit ready at all times and participate in internal / external inspections.

Basic Requirements :

• Bachelor of Science Degree in Engineering or related field (e.g. biology, chemistry, computer science, etc.)
• 3+ years supporting cGMP manufacturing.

Additional Skills / Preferences :

• Demonstrated relevant experience in a cGMP facility
• Prior experience in C&Q, CSQ, and / or CSV
• Proficient with computer systems including Microsoft Office, electronic document management systems (EDMS), Trackwise, Maximo, etc.
• Demonstrated solid judgment and initiative
• Ability to organize and prioritize multiple tasks and to problem solve effectively
• Ability to work under time pressure and exert good judgment in special situations
• Must exhibit good teamwork, communication and interpersonal skills sustained over time

Additional Information :

• This job is in Indianapolis, IN. Work will primarily occur on site with some flexibility for occasional remote work within the US.
• Travel to other locations may be necessary to support projects and / or complete training, but is not expected to be a significant percentage of the role.
• While uncommon, work outside of normal business hours may be needed to support activities related to operational issues.
• Applicant may work in various areas / buildings within PRD. Some allergens may be present. Mobility requirements and exposure to allergens should be considered when applying for this position.

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