QA Engineer, Foundry

Lilly Medicine Foundry 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. 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.

Responsibilities

The Foundry QA Engineer provides technical guidance and leadership in a variety of interactions with business and operations personnel. More specific examples include:

1. Provide consultation and interpretation of local procedures, corporate standards, and regulatory expectations.
2. Review and approve applicable procedures to ensure compliance with corporate standards and regulatory requirements.
3. Assess potential gaps between local procedures and corporate standards and facilitate remediation efforts.
4. 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.).
5. Influence and oversee Maintenance/Calibration programs within the Foundry, including benchmarking with other Lilly sites.
6. 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).
7. Escalate and/or initiate notification to management for departures of critical nature and assure issues are addressed appropriately.
8. Ensure the Foundry 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.) + Previous experience supporting cGMP manufacturing (QA, TSMS, operations, engineering, auditing, etc.).

Additional 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), 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

Other Information

+ Initial location at Lilly Technology Center, Indianapolis. + Permanent location at the new Lilly Medicines Foundry in Lebanon, Indiana. Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status. #WeAreLilly Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response. Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, national origin, protected veteran status, disability, or any other legally protected status. Our employee resource groups (ERGs) offer strong support networks for their members and are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women's Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups. Actual compensation will depend on a candidate's education, experience, skills, and geographic location. The anticipated wage for this position is $63,000 - $162,800 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). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly's compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees. #WeAreLilly