C&Q Engineer // Johnson & Johnson
Randstad
Bern, CH
vor 11 Tg.

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 134,000 people.

Janssen Vaccines in Bern (Switzerland) belongs to the Janssen Pharmaceutical Companies of Johnson & Johnson. Janssen is an organization of over 30,000 professionals working passionately to prevent, treat, cure and stop some of the most devastating and complex diseases of our time.

In Bern, about 300 people of over 20 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

  • Support 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 in QC

  • Plan, coordinate and execute all phases for qualification of QC Lab systems 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 QC Lab 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 QC Lab systems 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
  • Experience in QC environment is a plus
  • 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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