Microbiologist

Vor 2 Tagen


Le Locle, Schweiz Jabil Vollzeit

At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. With over 260,000 diverse, talented and dedicated employees across 100 locations in 30 countries, our vision is to be the most technologically advanced and trusted manufacturing solutions provider. We combine an unmatched breadth and depth of end-market experience, technical and design capabilities, manufacturing know-how, supply chain insights and global product management expertise to enable success for the world's leading brands. We are driven by a common purpose to make a positive impact for each other, our communities, and the environment.

**MAIN TASKS**:

- Establish and maintain procedures, tools and methodologies to cover the Jabil contamination control program (clean room monitoring, product monitoring, water monitoring, compressed air monitoring)
- Conduct radiation sterilization validations according to ISO 11137, and establish/maintain the bioburden and dose audit programs
- Maintain knowledge of FDA & ISO Environmental Monitoring and Product Cleanliness guidelines, as applicable
- Conduct technical assessments and support audits as Subject Matter Expert for contract laboratories and critical suppliers
- Conduct risk assessments from a contamination control perspective
- Provide guidance and training to personnel to ensure contamination control program requirements and good manufacturing/good documentation practices are met
- Work with the management to establish plant specific environmental monitoring requirements
- Provide input on design of manufacturing processes, controlled environments and finishing, including cleaning, to ensure their efficacy, for obtaining clean and safe products
- Provide input on design of systems to generate processed water
- Support validation of processed Water, controlled environment and finishing/cleaning processes
- Evaluate changes in the manufacturing processes (i.e internal process changes, external process changes, product transfers, etc.)
- Perform compliance tasks (CAPA, Nonconformances, Audit Observations) and support internal and external audits (Tüv, FDA, CFDA, etc.)
- Support projects accross-sites (travel up to 30% to other production sites)

**JOB REQUIREMENTS**:

- Bachelor or Master degree in Microbiology/Biology
- At least 2 year's work experience in the medical device and/or pharmaceutical industry is a must
- Experience with sterilization of medical devices is an advantage
- Knowledge in Good Manufacturing Processes
- Knowledge in regulations and industry guidelines applicable to cleanrooms (i.e. ISO/EN/AAMI standards) is preferred
- This position requires the ability to interact with managers as well as manufacturing personnel
- This position involves work in cross-functional groups, in an environment that embraces teamwork
- This international company offers employees an environment that encourages talent development
- Business fluency in French and English required, German would be an advantage

**Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, sexual orientation, gender identify, age, disability, genetic information, veteran status, or any other characteristic protected by law.


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