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Quality Assurance Engineering Specialist
2 months ago
At Eli Lilly, we merge compassion with innovation to enhance the lives of individuals globally. As a prominent player in the healthcare sector, our headquarters is located in Indianapolis, Indiana. Our dedicated workforce strives to discover and deliver transformative medications to those in need, enhance disease comprehension and management, and contribute to our communities through charitable efforts and volunteer work. We are seeking individuals who are committed to improving lives worldwide.
The Quality Assurance Engineer plays a pivotal role in overseeing, guiding, and supporting the areas of Facilities, Utilities, Maintenance, and Equipment. This position is crucial for ensuring compliance with Good Manufacturing Practices (GMP) and for providing assistance during preparations for inspections by various regulatory bodies.
Key Responsibilities:
- Serve as a Subject Matter Expert (SME) for Facilities, Utilities, Maintenance, and Equipment (FUME), collaborating with Global Facilities Delivery, project teams, and quality assurance groups to finalize the design of assigned areas while adhering to Quality by Design (QbD) and Quality Risk Management (QRM) principles.
- Coordinate with global and project teams to align design and startup activities with overall project timelines.
- Engage with global quality groups to ensure a consistent and compliant approach throughout the project lifecycle.
- Conduct technical and quality reviews of project documentation to ensure alignment with Eli Lilly's Global Quality Standards.
- Coordinate with global and project teams to align design and startup activities with overall project timelines.
- Oversee the verification and qualification processes for facility, utility, and maintenance systems, including the review of testing protocols and resolution of discrepancies.
- Collaborate with the Site Compliance Manager to develop a strategic vision for site quality operations, particularly in FUME areas.
- Assist in enhancing technical capabilities across a diverse team in Quality and project management, including mentoring new staff.
- Promote a robust quality culture through open communication and teamwork.
- Lead initiatives that support project and quality objectives.
- Address compliance issues promptly, escalating them as necessary to project and quality management.
- Support the execution of site readiness plans, focusing on the quality oversight of FUME systems.
- Ensure adherence to safety protocols, fostering a safe work environment for all.
- Participate in self-led inspections and assist during regulatory inspections.
- Review and revise documents to ensure quality standards are met.
- Engage in continuous improvement initiatives to enhance productivity within the quality organization.
- Bachelor's degree in engineering, computer science, or a related scientific field preferred.
- A minimum of 3 years of experience in pharmaceutical quality assurance roles.
- Experience with pharmaceutical FUME systems is advantageous.
- Commitment to maintaining a safe work environment and supporting HSE goals.
- Experience with facility or area startup processes.
- Familiarity with GMP utilities such as Water for Injection (WFI) and Clean Steam.
- Experience with maintenance systems is beneficial.
- 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 related regulations.
- Strong oral and written communication skills are essential.
- Proficient technical writing skills are required.
- Ability to work standard hours, Monday through Friday.
- Willingness to work overtime as needed.
- Occasional travel may be required for meetings and coordination with global regulatory organizations.
- This position allows for flexible working arrangements during project phases.
- Short-term assignments may be necessary to establish global contacts.
