Microbiological Process Specialist

vor 4 Wochen

Bern, Bern, Schweiz Randstad Vollzeit

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 Johnson & Johnson 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 120,000 people.Johnson & Johnson Innovative Medicine is a global pharmaceutical 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 environmental and utilities monitoring, including trending, hygiene, cleaning and gowning all in accordance with corporate and health authority regulationsProvide microbiological expertise for cleanroom environment/purified water systems routine testing programsProvide microbiological expertise to the Qualification and Validation teams to ensure appropriate performance-qualification (PQ) of cleanrooms and utilitiesEnsure that new manufacturing processes, or process changes meet biocontamination control principles and sterility assurance requirementsSupport as SME the execution of Quality investigations related to contamination control issuesSetting Contamination control KPIs and metricesResponsible for achieving harmonized and compliant of processes on siteTrain and qualify operators on current procedures and best practicesSupport the site during audits/inspection
Qualifikationen Who we are looking for A minimum of a bachelor's degree in microbiology, biology, engineering, or equivalent pharma discipline3+ years of experience in a GMP environment, in a pharmaceutical, or similar regulated industry with detailed knowledge of relevant regulations and standardsMicrobiological Quality and Sterility assurance expertiseUnderstanding of contamination control for manufacturing processes and thorough knowledge in cleanrooms environmentsExperience with the requirements for pharmaceutical utilities (i.e., purified water systems, pharma-grade gases, steam) is preferredDemonstrated collaborative nature and proactive communication skills to work efficiently and effectively in a diverse community on cross-functional project teamsExcellent organizational and time management skillsThis 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, inclusive and collaborative environment, then send us your application today. Or give us a call if you have any questions

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