Job Detail

IT - CSV Engineer

Inseriert am: 15.01.2019

  • Job TitleIT - CSV Engineer

  • Vacancy Reference Number11098

  • Work SiteSwitzerland / | CHE - All Regions / Basel

  • Contract TypePermanent [Full-Time]


Our offer



  • A permanent contract with the leader in innovation and high-tech engineering consulting

  • A multi-stage model with career opportunities through specialization prospects, as well as with over 45'000 consultants around the world and revenue of EUR. 2.9 Bn, the Altran Group is the undisputed global leader in Engineering and R&D services (ER&D).

  • In Switzerland, Altran employs more than 250 consultants and aims towards large growth with offices located in Zürich, Basel, Lausanne and Geneva.

  • Altran deploys its expertise particularly in:

    • Life Sciences (Pharma, Biotech, and Medical Devices),

    • Industry, Aerospace, Automotive, Energy, Railways,

    • Financial Services: P&C Insurance, Health Insurance, Reinsurance, Banking

    • Telecoms

    • Public sector



Your role



  • Lead validation activities of Computerized Systems in the Life Sciences Industry

  • Assist in maintaining equipment automation systems in a validated state as they relate to GxP CSV automation systems.

  • Execute QA reviews and approvals of IT SOPs, and validate master plans for computerized system implementations.

  • Develop an appropriate document control capability and ensure all documents filings and archiving systems are accurate, up to date and maintained in accordance with GMP and other relevant regulations.

  • Establish and ensure good and close working relationship with important project stakeholders and internal customers.


Your profile



  • MSc Degree in engineering, IT, Science or Computer related discipline.

  • 5 years proven track record in Computer System Validation in Pharmaceutical or Life Science environment.

  • Strong project management skills with the ability to prioritize assignments

  • Familiar with GxP systems.

  • Fluent knowledge of GAMP 5, Annex 11, CFR Part 11 Compliance and CFR Part 210, 211 & 820 compliance.

  • Excellent analytical and problem solving skills.

  • Languages: English fluent and German is a plus

Details