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Aseptic process engineer

CAI

Varese

In loco

EUR 30.000 - 50.000

Tempo pieno

30+ giorni fa

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Descrizione del lavoro

A leading company in the pharmaceutical manufacturing industry is looking for a qualified professional to support Sterility Assurance in regulated environments. The successful candidate will help in environmental qualifications and contamination control strategies while ensuring compliance with industry standards. Applicants must have a degree in a related science field and strong organizational skills to manage technical documentation. Travel may be required.

Competenze

  • Bachelor's degree in microbiology, biology, biotechnology or related field.
  • Experience with aseptic processes and good documentation practices required.
  • Strong attention to detail and organizational skills necessary.

Mansioni

  • Support Sterility Assurance assessment in regulated manufacturing.
  • Participate in cross functional projects including customer meetings.
  • Write protocols, reports, and specifications.

Conoscenze

Attention to Detail
Organizational Skills
Independence
Understanding of Good Documentation Practices
Experience with Aseptic Technique

Formazione

Degree in Microbiology, Biology, Biotechnology or Science-related Field

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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