The Associate Director - Quality Engineering is responsible for demonstrating leadership, teamwork, and quality and regulatory knowledge to lead the Quality Engineering team to provide guidance, consultation and oversight of the design, verification, startup, and ongoing life cycle management of the site facilities, utilities, and equipment. The position is essential for ensuring GMP compliance in the design, delivery, verification, qualification, start up, and life cycle maintenance of site assets, utilities and processes, maintain external linkages and support preparation for pre-approval and general inspections by regulatory agencies.
Requirements
- At least 7 years of quality knowledge and expertise in parenteral, clean utilities, and / or device and packaging manufacturing.
- Previous experience with C&Q / Verification and Validation oversight including automation and computer systems validation.
- Previous experience with capital project delivery.
- Demonstrated knowledge and use of US, EU, Japan and other regulations in the area of facilities, utilities, and equipment.
- Proficiency with computer systems including Microsoft office products, Trackwise, etc.
- ASQ Certified
- CSQA experience.
Responsibilities
- Lead a team of experienced Quality Engineers in providing cGMP and Lilly Global Quality Standard expertise working with Global Facility Delivery team, site engineering team, Lilly site staff, and selected A&E firm to support the verification and qualification of site facilities, utilities, and equipment, employing QbD and QRM principals and ensuring the integration of Global Quality System requirements into the design.
- Interact with the other global, project and functional areas to coordinate design and start up activities to support the overall project and site schedule.
- Consult with Network and Global quality groups including the Global Quality Systems, Engineering Technical Center, Global Parenteral Program, Pharmaceutical Delivery Systems, Global Packaging and Sterility Assurance Hub as required to ensure site team provides consistent and compliant approach is executed through start up and go-live phase.
- Provide technical and quality review and approval of project documents to ensure compliance with Lilly Global Quality Standards as well as project and local quality procedures.
- Provide quality oversight for the verification and qualification of the parenteral building, including review of test cases, test execution, discrepancy resolution, etc.
- Lead team in providing continued engineering oversite for post project work including: Ongoing equipment life cycle equipment changes, upgrades, improvements conducted during shutdowns.
- Site local capital project implementation support.
Other
- Bachelor's degree in a science, engineering, computer, pharmaceutical related field of study
- Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for this employment position.
- Demonstrated ability to communicate with cross-functional teams including good oral and written communication skills.
- Demonstrated Leadership capability leading a team.
- Ability to work 8 hour days – Monday through Friday
