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Aseptic process engineer

CAI

Italia

In loco

EUR 50.000 - 70.000

Tempo pieno

30 giorni fa

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Descrizione del lavoro

An established industry player is seeking a dedicated professional to support sterility assurance in the regulated manufacturing sector. This role involves assessing contamination control strategies, executing sterilizing equipment qualifications, and participating in cross-functional projects. The ideal candidate will have a degree in microbiology or a related field, with a strong focus on aseptic techniques and documentation practices. If you are detail-oriented and thrive in a collaborative environment, this opportunity offers the chance to contribute significantly to the quality and safety of pharmaceutical products while working in a dynamic team.

Competenze

  • Degree in microbiology or related field is essential.
  • Experience with aseptic techniques and contamination control is crucial.

Mansioni

  • Support sterility assurance assessments in regulated manufacturing.
  • Participate in writing protocols and reports for projects.

Conoscenze

Sterility Assurance
Environmental qualification
Contamination control Strategy
Aseptic process simulation
Sterilizing equipment qualification
Microbiological methods
Biological methods
Documentation practices
Organizational skills

Formazione

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

Descrizione del lavoro

Requested Skills:

  1. Support Sterility Assurance assessment in regulated manufacturing industry.
  2. Experience in Environmental qualification and Contamination control Strategy.
  3. Experience in aseptic process simulation risk assessment, validation strategy and oversight.
  4. Experience in Contamination control strategy of pharmaceutical sterile products.
  5. Execution of sterilizing equipment qualification.
  6. Experience in microbiological and biological method application and validation.
  7. Participates in cross functional projects, including customer meetings.
  8. Participates in the writing of protocols, reports, and specifications.
  9. Drives deliverables to completion with structured timelines.

Requested Qualifications:

  1. Degree in microbiology, biology, biotechnology or science-related field.
  2. Understanding of good documentation practices and general quality laboratory function.
  3. Ability to work independently.
  4. Strong attention to details, organizational skills and drive to be successful.
  5. 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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