QA Engineer, Foundry

Eli Lilly and Company-posted about 1 month ago

$63,000 - $162,800/Yr

Full-time • Mid Level

Indianapolis, IN

5,001-10,000 employees

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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 recently announced a $4.5 billion investment to create the Lilly Medicine Foundry, a new center for advanced manufacturing and drug development. The first-ever facility of its kind, combining research and manufacturing in a single location, the Medicine Foundry will allow Lilly to further develop innovative solutions to optimize manufacturing processes and increase capacity for clinical trial medicines, while also reducing costs and environmental impact. The Lilly Medicine Foundry QA Engineer is responsible for oversight of Facilities, Utilities, Maintenance, and Equipment (FUME) and computer systems (CSQ) within the Foundry and assures compliance with quality systems and current Good Manufacturing Practices (cGMP). This oversight includes supporting drug substance manufacturing, central utilities, warehouse, and laboratory facilities. This role is part of a team supporting the design, construction, and qualification at the Foundry as this new manufacturing site is built at a green field site.

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 the Foundry, 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 the Foundry 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.)
Previous experience supporting cGMP manufacturing (QA, TSMS, operations, engineering, auditing, etc.).

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), Kneat, 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

Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance).
In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for 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; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).

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