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Sterility assurance engineer

Cagents
Location
Italy
Posted
24 days ago
Department
South Europe
What they actually want (must-haves)
  • Experience with microbiological and biological methods, including method application and validation
  • Understanding of quality systems, GMP regulations, and Good Documentation Practices
  • Familiarity with Annex 1 requirements and sterile manufacturing principles
  • Experience with aseptic techniques and biological safety cabinets
  • Ability to work independently while managing multiple priorities
  • Strong attention to detail, organizational skills, and problem-solving capabilities
Nice to have
  • Intermediate level professional with hands-on experience in sterility assurance and aseptic process validation activities
  • Capable of independently managing documentation and coordinating assigned activities
  • Strong communication and stakeholder management skills
  • Comfortable working in cross-functional and project-based environments
What the job really is

The Sterility Assurance Engineer role at CAI involves applying microbiological and biological methods, ensuring compliance with quality systems and GMP regulations, and validating aseptic processes. The engineer will manage documentation, coordinate activities, and support field execution while working independently and handling multiple priorities in a cross-functional environment.

Things to weigh
  • No salary listed
  • Role involves travel which may affect work-life balance
  • Focus on quality and compliance may lead to high-pressure situations
Job score2.6/5
Benefits1/5
Freshness4/5
Career value4/5
Role clarity4/5
Pay transparency0/5

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