Microbiological QA Specialist // Johnson & Johnson
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 126,500 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.
Janssen Vaccines AG, 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 Microbiological Quality Assurance Specialist provides Microbiological Control support for API manufacturing in the Janssen Vaccines, Bern facility. You will apply scientific rationale, technical knowledge and expertise in industrial microbiology to support your customers and enable them to reach and maintain a state of biocontamination control and ensure compliance to internal and external standards and regulations.
Support the Head of Microbiology in the development, deployment, and maintenance of procedures for environmental monitoring and biocontamination control, hygiene, aseptic processing and sterility assurance, all in accordance with corporate and health authority regulations
Develop, deploy, and maintain procedures for environmental monitoring and hygiene to ensure appropriate microbiological quality of the products
Support Production and QC departments in the development of bioburden and endotoxin testing program and 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 are compliant and meet biocontamination control principles and sterility assurance requirements
Manage biocontamination control-related non-conformances and CAPAs including root cause analyses and corrective action implementation
Support the site during audits/inspection with Sterility Assurance topics
Who we are looking for
A minimum of a Bachelor’s degree in microbiology, biology, engineering, or equivalent discipline.
2+ years of experience in a GMP environment, in a pharmaceutical, or similar regulated industry.
Comprehensive experience of working in a Quality environment with detailed knowledge of relevant regulations and standards.
Must have a deep understanding of contamination control for manufacturing processes and thorough knowledge in cleanrooms environments.
Familiar with the requirements for pharmaceutical utilities (i.e., purified water systems, pharma-grade gases, steam).
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 based in Bern, Switzerland will initially be limited to approx. 12 months. If you are interested in working in one of the worlds most advanced pharmaceutical R&D environments in a challenging role, then send us your application today. Or give us a call if you have any questions!