Regulatory Compliance Engineer

7 days ago


St Louis, Missouri, United States Thermo Fisher Scientific Full time

**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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