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 260 operating companies in more than 60 countries employing approximately 135,000 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.
Janssen Vaccines in Bern (Switzerland) belongs to the Janssen Pharmaceutical Companies of Johnson & Johnson. Janssen is an organization of over 40,000 professionals working passionately to prevent, treat, cure and stop some of the most devastating and complex diseases of our time. In Bern, about 400 people of over 25 nationalities work together with the wider Janssen organization and partners on the development, manufacturing and analytical testing of novel vaccines and bacteria-based pharmaceutical products. We are committed to bringing meaningful innovation to global health by combating major threats to the health of people worldwide.
- Support in the development, deployment, and maintenance of procedures for environmental monitoring and biocontamination control, including trending, hygiene, aseptic processing and sterility assurance, cleaning 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 Validation team to ensure appropriate qualification/validation of sterilization cycles and performance-qualification (PQ) of cleanrooms and utilities
- Ensure that new manufacturing processes, or process changes meet biocontamination control principles and sterility assurance requirements
- Manage biocontamination control-related non-conformances (out of specification; out of limit; and out of trend results) and CAPAs including root cause analyses and corrective action implementation
- Responsible for achieving harmonized and compliant of Micro processes on site.
- Develop microbiological KPIs and metrices
- 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
- 2+ years of 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 cleanrooms environments is a major plus
- 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 is based in Bern, Switzerland and will initially be limited to 12 months. If you are interested in working for a global leading health care company, in a highly dynamic and flexible work environment, then send us your application today. Or give us a call if you have any questions!