Ingenieur Microbilogy

Main Responsibilities

• Provide expertise in the development, deployment, and maintenance of procedures for contamination control, aseptic processing and sterility assurance, such as environmental and utilities monitoring, including trending, hygiene, cleaning and gowning all in accordance with corporate and health authority regulations
• Provide microbiological expertise for cleanroom environment/purified water systems routine testing programs
• Provide microbiological expertise to the Qualification and Validation teams to ensure appropriate performance-qualification (PQ) of cleanrooms and utilities
• Ensure that new manufacturing processes, or process changes meet biocontamination control principles and sterility assurance requirements
• Support as SME the execution of Quality investigations related to contamination control issues
• Setting Contamination control KPIs and metrics
• Responsible for achieving harmonized and compliant of processes on site
• Train and qualify operators on current procedures and best practices
• Support the site during audits/inspection

Who we are looking for

• A minimum of a bachelor’s degree in microbiology, biology, engineering, or equivalent pharma discipline
• 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 the requirements for 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 job based in Bern, Switzerland will initially be limited to approx. 12 months with possibility of an extension.