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Senior Engineer Microbiology & Compliance // Johnson & Johnson.

job details

summary.

  • specialism
    life sciences
  • contact
    Stephan Zoebeli
  • reference number
    127140-593

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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 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 120,000 people.

Janssen Vaccines, 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 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 microbiological expertise in the development, deployment, and maintenance of procedures for contamination control, aseptic processing, and sterility assurance, such as zone concept, environmental and utilities monitoring (including trending), clean rooms cleaning, material hygiene, 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 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.
  • Lead E2E contamination control-related investigations (out of specification; out of limit; and out of trend results) Perform root cause analysis, action plan setting, implementation, and effectiveness.
  • Responsible for achieving harmonized and in compliance Contamination control processes on site
  • Setting microbiological KPIs and metrics
  • Train and qualify operators with current procedures and best practices.
  • Support the site during audits/inspection for Micro processes and Sterility Assurance topics

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 120,000 people.

Janssen Vaccines, 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 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 microbiological expertise in the development, deployment, and maintenance of procedures for contamination control, aseptic processing, and sterility assurance, such as zone concept, environmental and utilities monitoring (including trending), clean rooms cleaning, material hygiene, 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 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.
  • Lead E2E contamination control-related investigations (out of specification; out of limit; and out of trend results) Perform root cause analysis, action plan setting, implementation, and effectiveness.
  • Responsible for achieving harmonized and in compliance Contamination control processes on site
  • Setting microbiological KPIs and metrics
  • Train and qualify operators with current procedures and best practices.
  • Support the site during audits/inspection for Micro processes and Sterility Assurance topics

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Stephan Zoebeli

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