Associate Director - Quality Engineering

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- Quality Engineering role at Bio Space

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- Quality Engineering role at Bio Space

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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.

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.

Key Objectives/Deliverables

• 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.
• Future global capital projects at the site.
• Work with the Site Quality Leader to support the development of the vision and strategy for the overall site quality operation.
• Support the site organization in building technical capability, for a diverse cross-functional staff in Quality Engineering, site quality team, project team, and area process teams, including mentoring of new Quality and other project staff.
• Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group.
• Support the definition and execution of inspection readiness activities as it relates to facility, utilities, equipment, and maintenance.
• Lead project initiatives needed in support of the project and Quality function.
• Resolve or escalate any compliance issues to the project, site, and Quality Management.

• Bachelor's degree in a science, engineering, computer, pharmaceutical related field of study
• At least 7 years of quality knowledge and expertise in parenteral, clean utilities, and / or device and packaging manufacturing.