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

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

In charge of commissioning and qualification (C&Q) and Computer System Validation (CSV) activities for Technical Services department in order to ensure that:
- 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 of production equipment and related computer system validation including but not limited 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/Master Degree in technical or natural sciences
  • A minimum of 2 years of working experience within pharma/Medical Device company in C&Q equivalent position
  • Know-how of Qualification requirements according to cGMP regulations
  • Know-how of CSV principles according to cGMP regulations (i.e. GAMP5)
  • Know-how of quality assurance principles
  • Experience working with cross-department stakeholders
  • Analytical thinking and problem-solving ability
  • Business fluency in English

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!

#diversity #50plus

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

Vollzeit, Teilzeit, Befristet

Veröffentlicht am 10.09.2021

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