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Quality Assurance Engineering Specialist
2 months ago
At Eli Lilly, we combine compassion with innovation to enhance the quality of life for individuals globally. As a prominent player in the healthcare sector, our headquarters is situated in Indianapolis, Indiana. Our dedicated workforce is engaged in the discovery and delivery of transformative medicines, enhancing disease comprehension and management, while also contributing to our communities through philanthropic efforts and volunteer activities. We prioritize our commitment to excellence and place people at the forefront of our mission.
The role of the QA Engineer is pivotal in ensuring oversight, guidance, and support in the domains of Facilities, Utilities, Maintenance, and Equipment. This position is crucial for upholding GMP compliance and facilitating preparations for inspections conducted by various regulatory bodies.
Key Responsibilities:
- Serve as a Subject Matter Expert (SME) for FUME, collaborating with Global Facilities Delivery, project teams, Global CSQA, and selected service providers to finalize the intricate design of assigned areas, employing Quality by Design (QbD) and Quality Risk Management (QRM) principles while ensuring alignment with Lilly's Global Quality System requirements:
- Coordinate with global, project, and functional teams to synchronize design and startup activities in support of the overall project timeline.
- Engage with Network and Global quality groups, including GQS and Global Quality, to ensure a uniform and compliant approach throughout the project and startup phases.
- Conduct technical and quality assessments and approvals of project FUME system documentation to ensure adherence to Lilly's Global Quality Standards and local quality protocols.
- Coordinate with global, project, and functional teams to synchronize design and startup activities in support of the overall project timeline.
- Provide quality oversight for the verification and qualification of facility, utility, and maintenance systems, including the review of test cases, execution of tests, and resolution of discrepancies.
- Collaborate with the Site Compliance Manager to shape the vision and strategy for the overall site quality operations, focusing on FUME areas.
- Assist in enhancing technical capabilities within a diverse cross-functional team, including mentoring new Quality and project personnel.
- Promote a robust quality culture by fostering open communication, teamwork, and employee engagement within the workgroup.
- Lead project initiatives that support both the project and Quality functions.
- Address or escalate compliance issues to project, site, and Quality Management as necessary.
- Support the QA Compliance team and site in executing the site readiness plan, focusing on startup and ongoing quality oversight of site FUME systems, including collaboration with the Utilities Process Team and Business Quality Assurance for local computer systems.
- Ensure adherence to safety protocols and maintain a secure work environment for oneself and others by supporting HSE corporate and site objectives.
- Engage in self-led inspections and provide assistance during internal and external regulatory inspections.
- Effectively review and/or redline documents to ensure compliance with quality standards (e.g., deviations, observations, procedures, technical studies, validation protocols, change controls, and engineering documents).
- Participate in continuous improvement initiatives aimed at enhancing productivity within the local process team or quality organization.
- Bachelor's degree in engineering, computer science, or a related scientific field is preferred.
- A minimum of 3 years of experience in pharmaceutical QA roles.
- Prior experience with Pharmaceutical FUME systems is essential.
- Commitment to maintaining a safe work environment and accountability for supporting all HSE Corporate and Site Goals.
- Experience with facility or area startup processes.
- Familiarity with GMP utilities, including WFI, Clean Steam, and Process Compressed Air.
- Experience with Maintenance systems is advantageous.
- Six Sigma Green Belt or Lean Training/Experience is preferred.
- Certification as a Quality Engineer (CQE) from the American Society for Quality (ASQ) is a plus.
- Experience with FUME systems qualification and relevant regulations is beneficial.
- Demonstrated strong oral and written communication skills and interpersonal abilities.
- Proven technical writing skills are essential.
- Ability to work 8-hour shifts, Monday through Friday.
- Willingness to work overtime as required.
- Ability to travel up to 10% for meetings and coordination with global regulatory organizations and support of site activities as needed.
- This position allows for a flexible working environment during the project phase, with the possibility of remote work based on project requirements and site activities.
- Short-term assignments may be required to establish global contacts.
