Hybrid Sterility Assurance Expert

Posted last month

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About the role

  • Leads Sterility Assurance assessment in regulated manufacturing industry.
  • Environmental qualification and contamination control strategy development and execution.
  • Aseptic process simulation risk assessment, validation strategy and oversight.
  • Contamination control strategy implementation for pharmaceutical sterile products.
  • Execution and oversight of sterilizing equipment qualification.
  • Application and validation of microbiological and biological methods.
  • Participation in cross-functional projects and customer meetings.
  • Writing of protocols, reports, and specifications.
  • Driving deliverables to completion within structured timelines.
  • Availability for travel throughout Italy and occasional European travel.

Requirements

  • Leads Sterility Assurance assessment in regulated manufacturing industry.
  • Experience in Environmental qualification and Contamination control Strategy.
  • Experience in aseptic process simulation risk assessment, validation strategy and oversight.
  • Experience in Contamination control strategy of pharmaceutical sterile products.
  • Execution of sterilizing equipment qualification.
  • Experience in microbiological and biological method application and validation.
  • Participates in cross functional projects, including customer meetings.
  • Participates in the writing of protocols, reports, and specifications.
  • Drives deliverables to completion with structured timelines.
  • Degree in microbiology, biology, biotechnology or science-related field
  • Understanding of good documentation practices and general quality laboratory function.
  • Ability to work independently and manage multiple projects simultaneously.
  • Strong attention to details, organizational skills and drive to be successful.
  • Experience with aseptic technique and biological safety cabinets.
  • Proficient in spoken and written English and /or a native language
  • Suitable candidates must be available for travel throughout Italy and some European travel may be required.

Job title

Sterility Assurance Expert

Job type

Experience level

Mid levelSenior

Salary

Not specified

Degree requirement

Bachelor's Degree

Location requirements

HybridItaly

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