Senior CSV Engineer (f/m/x) // Johnson & Johnson

☞ Make A Healthy Change

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Update day: 21-03-2024

Location:

Category: High Technology Mechanical / Technical Electrical / Electronics IT - Software

Industry:

Position: Associate

Job type: Full-time

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Job content

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 135,000 people.

Janssen Vaccines in Bern (Switzerland) belongs to the Janssen Pharmaceutical Companies of Johnson & Johnson. Janssen is an organization of over 40,000 professionals working passionately to prevent, treat, cure and stop some of the most devastating and complex diseases of our time. In Bern, about 400 people of over 25 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.

Main Responsibilities
  • Leading commissioning and qualification (C&Q) activities for Technical Services department to ensure:
  • Qualification/Validation phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities
  • Qualification/Validation Master plans are up to date and established for all ongoing projects
  • Plan, coordinate and execute all phases for qualification mited to validation plans, FMEA, RTM, DQ, IQ, OQ, PQ.
  • Prepare, review and approve technical and GMP related documentation (URS, impact/risk assessment, Master plans, qualification/validation documentation)
  • Coordinate and execute FAT/SAT, commissioning activities for new systems in collaboration with internal and external partners
  • Coordination and oversight of external subcontractors
  • Operational handling of Change Controls, CAPAs and Non-Conformances related to qualification and CSV
Who We Are Looking For
  • Bachelor or Master’s Degree in technical or natural sciences
  • A minimum of 2 years of working experience within a highly regulated environment
  • Know-how of Qualification requirements according to cGMP regulations is a major plus
  • Know-how of quality assurance principles
  • Excellent communication skills, Analytical thinking and problem-solving ability
  • Business fluency in English, German is a plus
  • Team player, self-motivated, strong multitasker and a good time manager
This role based in Bern, Switzerland will initially be limited to approx. 12 months. If you are interested in working for a global leading health care company, then send us your application today. Or give us a call if you have any questions!
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Deadline: 05-05-2024

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