Sr. Principal Associate, Quality Engineering

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 is building a next-generation biotech drug substance manufacturing facility in Richmond, VA-our most technically advanced site to date. This greenfield facility will feature cutting-edge manufacturing technologies and advanced data platforms designed to drive improvements in safety, quality, and productivity. This is a rare opportunity to shape an organization, a facility, and a culture from the ground up.

** Responsibilities:*
* + The Sr. Principal Associate - Quality Engineering leads the Quality Engineering team, applying strong leadership, teamwork, and quality and regulatory expertise. The role provides guidance, consultation, and oversight across the design, verification, startup, and ongoing life cycle management of site facilities, utilities, and equipment. It is essential to ensuring cGMP compliance throughout the design, delivery, verification, qualification, commissioning, startup, and life cycle maintenance of site assets, utilities, and processes.

The role also maintains external linkages and supports preparation for pre-approval and general inspections by regulatory agencies.

** Key Objectives/Deliverables:*
* + Provide cGMP and Lilly Global Quality Standard expertise working with Global Facility Delivery team, site engineering team, Lilly site staff, and selected firm to support the verification and qualification of site facilities, utilities, and equipment, employing Quality by Design (QBD) and Quality Risk Management principals and ensuring the integration of Global Quality System requirements into the design.

+ 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.

+ Provide coaching, feedback and mentoring to engineering and QA as it relates to execution of quality systems.

+ Maintain and improve facility, utility, maintenance, and equipment (FUME) quality systems.

+ Contribute to and review Annual Product Reviews (APR), Quarterly Product and Process Self-Assessments (QPPA), Asset qualification maintenance system strategies and equipment/computer system periodic reviews, as appropriate.

+ Conduct gap assessments of global requirements and ensure implementation of the governing standards.

+ Maintain and improve FUME quality systems.

+ Assist business partners in the interpretation of regulatory and corporate requirements.

+ 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.

+ Foster a strong quality culture including maintaining open communications and promoting teamwork and employee participation in the work group.

+ Resolve or escalate any compliance issues to the project, site, and Quality Management.

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* Basic Qualifications:

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* + BS in Engineering or a science-related field or equivalent experience.

+ Minimum of 8 years of relevant experience required.

+  _Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1._

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* Skills:

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* + Previous experience with Commissioning & Qualification (C&Q) / Verification and Validation oversight including automation and computer systems validation (CSV).

+ Experience in API/drug product manufacturing, QA or Engineering. Must have hands-on experience with quality engineering related documentation review/approval

+ Previous experience with capital project delivery.

+ Demonstrated knowledge and use of US, EU, Japan and other regulations in facilities, utilities, and equipment.

+ Demonstrated ability to communicate with cross-functional teams including good oral and written communication skills.

+ Demonstrated strong written and verbal communications skills.

+ Strong attention to detail.

+ Proficiency with computer system applications.

+ Knowledge of cGMPs and quality systems.

+ Understanding of statistical tools and analysis.

+ Excellent interpersonal skills and networking skills.

+ Ability to organize and prioritize multiple tasks, work under multiple priorities and…