Job Description
Senior Quality Engineer sought to maintain quality and regulatory compliance of biopharmaceutical products in a next-generation manufacturing facility.
Lilly is a global healthcare leader headquartered in Indianapolis, Indiana. We unite caring with discovery to make life better for people around the world. Our employees 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.
Eli Lilly Limerick is a cutting-edge biotechnology company dedicated to revolutionizing the healthcare industry through the development and production of next-generation biopharmaceuticals. Our state-of-the-art manufacturing facility employs the latest bioprocessing technologies to create life-saving therapies.
As a Senior Quality Engineer, you will play a critical role in maintaining the quality and regulatory compliance of our biopharmaceutical products. You will work closely with cross-functional teams to implement and uphold quality assurance standards, facilitate inspections and audits, and support continuous improvement initiatives.
Key Responsibilities:
- Quality Assurance Oversight:
- Influence and oversee Commissioning and Qualification (C&Q) of GMP assets, including review and approval of associated deliverables.
- Develop and maintain quality assurance procedures, policies, and systems.
- Conduct routine self-inspections and monitoring assessments to ensure compliance with cGMP and other relevant regulations.
- Investigate and address deviations, non-conformities, and CAPA.
- Regulatory Compliance:
- Stay current with industry regulations, guidelines, and best practices.
- Assist in the preparation and execution of regulatory inspections and audits.
- Ensure that all products meet regulatory requirements, including documentation and reporting.
- Documentation and Reporting:
- Maintain accurate and comprehensive quality records, including procedures, qualification documentation, change control documentation, and quality reports.
- Prepare and review documentation related to product quality and compliance, including GMP standard operating procedures, process flow documents, and equipment qualification and process validation documentation.
- Quality Improvement Initiatives:
- Identify areas for process improvement and work collaboratively with cross-functional process teams to implement changes.
- Participate in risk assessments and quality improvement projects.
- Training and Development:
- Provide training to staff on quality-related procedures and best practices.
- Stay informed about the latest developments in biotechnology and quality assurance.
Qualifications:
- BSc, Hons BSc, MSc, or PhD in Pharmacy, Science, Engineering, Quality, or related discipline.
- Minimum of 3-5 years of experience in quality assurance within a biotechnology or pharmaceutical manufacturing environment.
- Strong knowledge of cGMP, FDA, Data Integrity, Quality Risk Management, and other biopharmaceutical regulatory requirements.
- Excellent problem-solving and analytical skills.
- Detail-oriented with a strong commitment to maintaining high-quality standards.
- Effective communication and teamwork skills.
- Demonstrated initiative – able to work proactively without direct supervision and with a continuous improvement mind-set.
- Experience with quality management systems (e.g., TrackWise, GMARS), experience within or supporting pharmaceutical utilities and facilities, facility qualification, and cleaning validation programs are a plus.