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Specialist Microbiological Quality // Johnson & Johnson

Other
Bern
English

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:

  • Support the Head of Microbiology in the development, deployment, and maintenance of Microbiological Quality processes as well as Quality Control Labs to ensure a state of microbial control and compliance with global internal and external regulations
  • Support Quality Operations and Product Quality in ensuring GMP readiness for NPI projects and the GMP-compliant production of active ingredients and drugs for clinical trials and market launch
  • Provide Microbiological Quality Assurance expertise to site units to ensure appropriate qualification/validation of microbial control
  • Ensure that new manufacturing processes, or process changes meet biocontamination control principles and Microbiological Quality Assurance
  • Develop and deploy KPIs and Metrics and ensure CAPA effectiveness to achieve a state of consistent microbial control
  • Focus team member/SME for non-conformities and CC Review and approval of non-conformities, CAPAs and Change Controls
  • Ensure the relevancy and effectiveness of corrective and preventive actions
  • Review and approval of SOPs, work instructions and risk assessments
  • Support the site during audits/inspection

Requirements:

Who we are looking for:

  • University degree in microbiology, biology, engineering, or equivalent pharma 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 kledge of relevant regulations and standards
  • Understanding of contamination control for manufacturing processes and thorough kledge in cleanrooms environments is a major plus
  • Familiar 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
  • od communication skills in English language
  • Communication skills in German is a plus

This 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, progressive, and collaborative environment, then send us your application today. Or give us a call if you have any questions!