Johnson & Johnson Careers

Computer System Validation Engineer

Zuchwil, Switzerland
Validation


Job Description

Requisition ID: 1705615451W

DePuySynthes Companies of Johnson & Johnson is the largest, most comprehensive orthopedic and neurological business in the world. DePuy Synthes offer an unparalleled breadth and depth of technology, devices, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, cranio-maxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we are creating one organization that will be agile and better equipped in today’s evolving health care environment. Our broad array of inspired, innovative and high-quality offerings help advance the health and wellbeing of people around the world.

 

Based in our headquarters in Zuchwil, Solothurn we are looking for a highly committed

 

Computer System Validation Engineer

 
Your main tasks will include
 
  • The CSV Engineer is responsible for reviewing and approving validation deliverables of GxP regulated computerized systems to ensure full compliance with Health Authority regulatory requirements and adherence to company policies and procedures by supporting computer validation projects and base business support teams.
  • This position will be responsible for the approval of SDLC validation documentation deliverables, such as but not limited to Compliance Plans, User Requirements, User Acceptance Tests, Traceability Matrix, and the Compliance Report, including the approval to release system implementation and/or changes for production use
  • Works collaboratively with project teams, providing CSV guidance and support to project and/or base business support teams in the resolution of validation documentation corrections and/or test defects
  • Proactively monitors systems and processes to ensure compliance with standard operating procedures, audit compliance and industry best practices moving the organization towards a positive risk management posture
  • This position will support internal and external Health Authority regulatory audits, ensuring a high degree of Inspection Readiness for Systems in the CSV portfolio with the purpose of minimizing the risk of inspection observations to Business systems/infrastructure within CSV responsibility. 


Qualifications
  • A Bachelor’s degree or equivalent in Computer Science, Information Systems, Business Administration or other related field required; additional certifications a plus
  • A minimum of 5 years of Computer System Validation experience
  • Knowledge of software development and testing methodologies (S/W life cycle) is required
  • Direct experience supervising computer systems compliance activities in a GMP and/or ISO regulated environment is preferred
  • Medical device and/or pharmaceutical experience are preferred. Experience in managing and/or in performing audits is preferred
  • Excellent Organizational and Communication Skills (written and verbal) is required
  • Other than English, the ability to communicate in German and other languages is preferred
  • ASQ and Six-Sigma/Lean Certification as a Software Quality Engineer is a plus
 
If you feel attracted by this challenge and want to be part of a successful and growing organization, then please send us your online application (CV, Motivation Letter, Working References etc.) 

Primary Location
Switzerland-Solothurn-Zuchwil
Organization
Synthes GmbH (7111)
Job Function
Validation
Requisition ID
1705615451W