Sterility Assurance Manager

PPD (Thermo Fisher) UK

Competitive pyy; annual performance-based bonus; m...
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7 years microbiology experience
5 years leadership experience
Bachelor of science degree
** The Sterility Assurance Manager position at PPD (Thermo Fisher) UK is responsible for ensuring sterility assurance across the site and leading initiatives related to contamination control, environmental monitoring, and regulatory compliance. This role requires significant experience in microbiology within a sterile pharmaceutical manufacturing environment, as well as leadership capabilities. **

Job Summary

  • The Sterility Assurance Manager is accountable for defining and maintaining contamination control strategies across assigned sterile manufacturing areas.
  • This role requires leading sophisticated investigations into sterility issues, including adverse environmental monitoring trends and media fill failures.
  • Candidates will act as a Subject Matter Authority for regulators and clients while ensuring compliance with cGMP and Annex 1 standards.

Matching Summary

Match Score: 75

** The Sterility Assurance Manager position at PPD (Thermo Fisher) UK is responsible for ensuring sterility assurance across the site and leading initiatives related to contamination control, environmental monitoring, and regulatory compliance. This role requires significant experience in microbiology within a sterile pharmaceutical manufacturing environment, as well as leadership capabilities. **

Salary

Competitive Pay; Annual performance-based bonus; Medical, Dental, & Vision benefits effective Day 1

Skills & Requirements

Must-have

  • 7 years microbiology experience
  • 5 years leadership experience
  • Bachelor of Science degree
  • Aseptic processing knowledge
  • Media fill program oversight
  • Contamination control strategy

Nice-to-have

  • Capital project involvement
  • Root cause analysis methods
  • Strong diplomatic skills
  • Client-facing audit experience
  • Annex 1 transition expertise

Key Requirements

  • Bachelor of Science in Microbiology or Biology
  • 7 years of Microbiology experience required
  • 5 years of leadership experience required
  • Must be legally authorized to work in the US
  • No sponsorship provided for visa status

Work Rights

Must be legally authorized to work in the United States without sponsorship

Tailored Resume

Cover Letter