Johnson & Johnson Careers
Sterility Assurance Specialist
Requisition ID: 1905727875W
“Caring for the world … one person at a time” inspires and unites the people of Johnson & Johnson. This culture of caring is the focus of our corporate philosophy, that is anchored in the internationally applicable Credo. 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 134,000 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 30,000 professionals working passionately to prevent, treat, cure and stop some of the most devastating and complex diseases of our time. In Bern, about 300 people of over 20 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 bring meaningful innovation to global health by combating major threats to the health of people worldwide.
For our site in Bern we are looking for a highly committed
Sterility Assurance Specialist
The aim of this role is to support the Head of Q-Microbiology to ensure that microbiological quality of products, manufacturing facilities, and utilities meet company and health authorities’ standards and participates in the development of action plans to correct deficiencies and improve microbiological quality processes. Additionally, you will support the site Sterility Assurance oversight and support of Aseptic Processing Programs, Environmental Monitoring and Biocontamination Control Policies.
- Perform Shop-floor oversight of Aseptic Processing manipulations.
- Author/Review/Approve quality processes documents related to Sterility Assurance and Biocontamination Control.
- Proactive use of Quality System tools (Event Management; Risk-assessments; CCs; CAPAs, etc.) to warrant compliance and adherence to local, global, and HA requirements with regards to microbiology-related prevention and control policies.
- Author/Review/Approve study plans; analytical methods documents; specifications; memos; assessments; etc. as a Sterility Assurance/Biocontamination Control SME, consultant, team-member, of the relevant project.
- Support R&D teams in the implementation of new products (in accordance with NPI procedures) and provide microbiological expertise to support all site units with issues related to microbiological quality.
- Support supplier audits and vendor qualification activities as required. Support the development and implementation of the site Biocontamination Prevention Control programs, policies and Strategy.
- Lead investigations pertaining to microbial contaminations to ensure identification of effective root-cause analyses, assignment of appropriate corrective actions and determinations and remediation plans.
- Training staff on technical Aseptic Processing and Sterility Assurance concepts and techniques.
- A minimum of a Master’s degree in Microbiology, Life sciences, or equivalent technical discipline is required.
- A minimum of 3 years of experience in Sterility Assurance, Biocontamination Control, Quality Assurance or other Quality unit related to Pharmaceutical Microbiology in GMP manufacturing is required.
- Microbiology experience related to manufacturing and environmental monitoring (e.g. biocontamination investigations, trending, EM reports, etc.).
- Experience with aseptic processing oversight and work in clean rooms.
- Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of Vaccines as well as knowledge of USP/EP chapters related to microbiological test methods.
- Good written and verbal communication skills are required; English is a must.
- On an exceptional basis, this role may require working outside normal business hours on little to no prior notice.
- Experienced in speaking and interacting with inspectors would be considered a plus.
- Good written and verbal communication skills in German are preferred.
Janssen Vaccines AG (8851)