Microbiologist

vor 2 Monaten


Bern, Bern, Schweiz Randstad (Schweiz) AG Vollzeit
Job Description

We are seeking a highly skilled Microbiologist to join our team at Randstad (Schweiz) AG. As a key member of our team, you will be responsible for ensuring the highest standards of quality and sterility in our manufacturing processes.

Main Responsibilities
  • Develop and implement procedures for contamination control, aseptic processing, and sterility assurance in accordance with corporate and health authority regulations.
  • Provide microbiological expertise for cleanroom environment and purified water systems routine testing programs.
  • Collaborate with the Qualification and Validation teams to ensure the appropriate performance-qualification of cleanrooms and utilities.
  • Ensure that new manufacturing processes or process changes meet biocontamination control principles and sterility assurance requirements.
  • Support the execution of Quality investigations related to contamination control issues.
  • Establish and track contamination control KPIs and metrics.
  • Ensure harmonized and compliant processes on site.
  • Train and qualify operators on current procedures and best practices.
  • Support the site during audits and inspections.
Requirements
  • A minimum of a bachelor's degree in microbiology, biology, engineering, or equivalent pharma discipline.
  • At least 3 years of experience in a GMP environment, in a pharmaceutical or similar regulated industry with detailed knowledge of relevant regulations and standards.
  • Microbiological Quality and Sterility assurance expertise.
  • Understanding of contamination control for manufacturing processes and thorough knowledge in cleanrooms environments.
  • Experience with pharmaceutical utilities (i.e., purified water systems, pharma-grade gases, steam) is preferred.
  • Demonstrated collaborative nature and proactive communication skills to work efficiently and effectively in a diverse community on cross-functional project teams.
  • Excellent organizational and time management skills.

This role is based in Bern, Switzerland and will initially be limited to approximately 12 months with the possibility of an extension.