Regulatory Compliance Engineer
7 days ago
**Quality Assurance Expert Wanted**
Thermo Fisher Scientific is seeking a Regulatory Compliance Engineer to join our team in St. Louis, MO.
The estimated annual salary for this position is $90,000 - $115,000, based on experience.
About the Job
This role involves working in a fast-paced biologic drug substance manufacturing facility, operating around the clock, with over 1,000 employees.
You will collaborate with multi-functional teams to develop, optimize, and improve processes to enhance efficiency, productivity, and quality.
Key Responsibilities
- Conduct thorough audits and inspections to ensure sustained compliance with industry standards and regulations
- Collaborate with Manufacturing and Process Engineering to supervise activities from a quality perspective
- Provide coaching to site colleagues to prevent contamination and cross-contamination
- Participate in client and regulatory audits as a SME on Fit and Finish, Changeover, and Change Control procedures and practices
Qualifications
- Bachelor's Degree (BA/BS) in Life Sciences, Engineering, or another science-related field combined with a minimum of three (3) years of relevant experience
- Experience with cell culture, protein purification, formulations, or facilities/utilities in a GMP pharmaceutical or biopharmaceutical environment is preferred
- Cleanroom manufacturing experience is highly preferred along with a comfort level with full ISO 5 and ISO 7 gowning requirements
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