Sterility Assurance Expert

CAI; Alessandria; In loco; EUR 40.000 - 60.000; Tempo pieno

Descrizione del lavoro

A prominent company in the manufacturing industry is seeking a qualified professional to lead Sterility Assurance assessments. Responsibilities include the validation of aseptic processes and participation in cross-functional projects. The successful candidate will have a strong educational background in microbiology or a related field and possess excellent organizational skills, along with proficiency in English.

Competenze

• Experience in Environmental qualification and Contamination control Strategy.
• Strong attention to details and organizational skills required.
• Proficient in spoken and written English or native language.

Mansioni

• Leads Sterility Assurance assessment in regulated manufacturing industry.
• Participates in writing of protocols, reports, and specifications.
• Drives deliverables to completion with structured timelines.

Conoscenze

Attention to detail

Organizational skills

Aseptic technique

Formazione

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

Descrizione del lavoro

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.

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 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.

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