Lilly PRD QA Engineer in Indianapolis, Indiana
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 35,000 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.
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.
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
Bachelor of Science Degree in Engineering or related field (e.g. biology, chemistry, computer science, etc.)
3+ years supporting cGMP manufacturing
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, SAP, 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
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.
Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
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Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.
As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!