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CSV Engineer // Johnson & Johnson

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CSV Engineer // 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 134,000 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.

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.

Main Responsibilities

  • Computer System Validation (CSV) activities for Technical Services department in order to ensure that:
    - Validation phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities
    - Validation Master plans are up to date and established for all ongoing projects
  • Plan, coordinate and execute all phases for computer system validation of production and QC Lab systems including but not limited to, Validation plans, FMEA, RTM, DQ, IQ, OQ, PQ test scripts
  • 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 focused on CSV for new systems in collaboration with internal and external partners
  • Ensuring completion of CSV Periodic Review activities and assessment of the required corrective actions
  • Validation planning for base business including interaction with IT, Maintenance Automation and Quality Operations groups
  • Coordination and oversight of external subcontractors / software suppliers
  • Operational handling of Change Controls, CAPAs and Non-Conformances related to CSV
  • Support Technical Services department KPI?


 

Who we are looking for

  • Bachelor/master's degree in technical or natural sciences
  • Work experience within pharma or a biotech company
  • Know-how of CSV requirements according to FDA 21CFR part 11/ EUGMP Annex 11 regulations and ISPE GAMP 5 guidelines
  • Basic know-how of Qualification requirements according to cGMP regulations
  • Basic know-how of quality assurance principles
  • Excellent communication skills
  • Analytical thinking and problem-solving ability
  • Ability to work under minimal supervision; Assess priorities and work well under pressure in a fast-paced environment
  • Ability to effectively work as part of a multidisciplinary, international team
  • Business fluency in English
  • German language is a plus

This role based in Bern, Switzerland will initially be limited to 12 months. If you are interested in working for a global leading health care company in a challenging role, then send us your application in English today. Or give us a call if you have any questions!

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