Quality Assurance Engineering Specialist

1 week ago

Denver, North Carolina, United States Eli Lilly Full time

At Eli Lilly, we combine compassion with innovation to enhance the lives of individuals globally. As a prominent leader in healthcare, our headquarters are situated in Indianapolis, Indiana. Our global workforce is dedicated to discovering and delivering transformative medicines, improving disease comprehension and management, and contributing to our communities through philanthropy and volunteer efforts. We strive for excellence in our work, prioritizing people above all. We seek individuals who are committed to enhancing lives worldwide.

The QA Engineer plays a crucial role in providing oversight, guidance, and support in the domains of Facilities, Utilities, Maintenance, and Equipment. This position is vital for ensuring compliance with Good Manufacturing Practices (GMP) and assisting in preparations for inspections 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 detailed design of assigned areas, applying Quality by Design (QbD) and Quality Risk Management (QRM) principles while ensuring adherence to Lilly's Global Quality System requirements:
    • Coordinate with global, project, and functional teams to align design and startup activities with the overall project timeline.
    • Engage with Network and Global quality groups, including GQS and Global Quality, to ensure a consistent and compliant execution throughout the project and startup phases.
    • Conduct technical and quality reviews of project FUME system documentation to guarantee compliance with Lilly's Global Quality Standards and local quality procedures.
  • 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 develop the vision and strategy for the overall site quality operations, focusing on FUME areas.
  • Assist in building technical capabilities within a diverse cross-functional team, including mentoring new Quality and project staff.
  • Promote a robust quality culture by maintaining open communication and encouraging teamwork and employee engagement.
  • 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, emphasizing startup and ongoing quality oversight of site FUME systems, while participating in the Utilities Process Team and Business Quality Assurance for local computer systems.
  • Ensure adherence to safety protocols and foster a safe working environment for all by supporting Health, Safety, and Environmental (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.
Basic Qualifications:
  • 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.
Additional Preferences:
  • Commitment to maintaining a safe work environment and supporting all HSE corporate and site goals.
  • Experience with facility or area startup processes.
  • Familiarity with GMP utilities, including Water for Injection (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.
  • Strong oral and written communication skills, along with effective interpersonal skills, are essential.
  • Proficient technical writing skills are required.
Additional Information:
  • Ability to work standard 8-hour days, Monday through Friday.
  • Willingness to work overtime as needed.
  • Ability to travel up to 10% for meetings and coordination with global regulatory organizations.
  • This position allows for a flexible working environment, with the possibility of remote work based on project phases and site activities.
  • Short-term assignments may be required to establish global contacts.
Eli Lilly and Company is committed to ensuring equal employment opportunities and fostering an inclusive workplace. We do not discriminate based on age, race, color, religion, gender, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other legally protected status.

Our employee resource groups provide robust support networks and help develop talented individuals for future leadership roles. Learn more about our commitment to diversity and inclusion.

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