Specialist Microbiology & Compliance // Johnson & Johnson
job details
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 regulations
- Provide 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
- Support as SME the execution of Quality investigations related to contamination control issues
- Setting Contamination control KPIs and metrices
- Responsible for achieving harmonized and compliant of processes on site
- Train and qualify operators on current procedures and best practices
- Support the site during audits/inspection
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 regulations
- Provide 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
- Support as SME the execution of Quality investigations related to contamination control issues
- Setting Contamination control KPIs and metrices
- Responsible for achieving harmonized and compliant of processes on site
- Train and qualify operators on current procedures and best practices
- Support the site during audits/inspection
- qualifications
Who we are looking for
- A minimum of a bachelor's degree in microbiology, biology, engineering, or equivalent pharma discipline
- 3+ years of experience in a GMP environment, in a pharmaceutical, or similar regulated industry with detailed knowledge of relevant regulations and standards
- Microbiological Quality and Sterility assurance expertise
- Understanding of contamination control for manufacturing processes and thorough knowledge in cleanrooms 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
À propos de l'entreprise
