Engineer Microbiology & Compliance // Johnson & Johnson

☞ Randstad Switzerland

View: 146

Update day: 30-03-2024

Location: Bern Bern BE

Category: Executive management Production / Operation

Industry: Staffing Recruiting

Position: Mid-Senior level

Job type: Full-time

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Job content

Caring for the world, one person at a time. inspires and unites the people of Johnson & Johnson. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. We have more than 265 operating companies in more than 60 countries employing approximately 140,000 people.Janssen Vaccines, one of the Janssen Pharmaceutical Companies of Johnson & Johnson, is a global biopharmaceutical company dedicated to bringing meaningful innovation to global health. We do this by discovering, developing, manufacturing and marketing products that combat major threats to the health of people worldwide. The Bern site, with its approx. 600 people of over 25 nationalities, acts as a center of expertise for development and manufacturing of innovative cell based viral- and bacterial vaccines and bacterial based therapeutic products.Main Responsibilities
  • Provide expertise in the development, deployment, and maintenance of procedures for contamination control, aseptic processing, and sterility assurance, such as zone concept, environmental and utilities monitoring (including trending), clean rooms cleaning, material hygiene, and gowning all in accordance with corporate and health authority regulations.
  • Provide the site with 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.
  • Lead E2E contamination control-related investigations (out of specification; out of limit; and out of trend results) Perform root cause analysis, action plan setting, implementation, and effectiveness.
  • Responsible for achieving harmonized and in compliance Contamination control processes on site
  • Setting microbiological KPIs and metrics
  • Train and qualify operators with current procedures and best practices.
  • Support the site during audits/inspection for Micro processes and Sterility Assurance topics
Who we are looking for
  • A minimum of a bachelor’s degree in microbiology, biology, engineering, or equivalent pharma discipline.
  • Work experience in a GMP environment, in a pharmaceutical, or similar regulated industry with detailed knowledge of relevant regulations and standards
  • Understanding of contamination control for manufacturing processes and thorough knowledge in cleanroom 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. If you are interested in working with a global leading pharmaceutical company in a dynamic, progressive, and collaborative environment, then send us your application today. Or give us a call if you have any questions!
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Deadline: 14-05-2024

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