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Aseptic process engineer

CAI

Firenze

In loco

EUR 35.000 - 50.000

Tempo pieno

8 giorni fa

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Descrizione del lavoro

A leading company in the pharmaceutical industry is seeking a qualified professional to support sterility assurance in a regulated manufacturing environment. The role encompasses responsibilities in contamination control strategies and quality assurance documentation, requiring a degree in microbiology or a related field. The successful candidate will work collaboratively in cross-functional teams and may need to travel domestically and internationally.

Competenze

  • Proficient in spoken and written English or a native language.
  • Understanding of good documentation practices.
  • Ability to work independently.

Mansioni

  • Support sterility assurance assessments in manufacturing.
  • Participate in writing protocols, reports, and specifications.
  • Participate in cross-functional projects and meetings.

Conoscenze

Strong attention to details
Organizational skills
Independence

Formazione

Degree in microbiology, biology, biotechnology or science-related field

Strumenti

Aseptic technique
Biological safety cabinets

Descrizione del lavoro

  • Support 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.

Requested Qualifications :

  • Degree in microbiology, biology, biotechnology or science-related field.
  • Understanding of good documentation practices and general quality laboratory function.
  • Ability to work independently.
  • Strong attention to details, organizational skills and drive to be successful.
  • Experience with aseptic technique and biological safety cabinets.

Essential : Proficient in spoken and written English and / or a native language.

Able to travel domestically and internationally if required.

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