CSV Engineer

Vor 5 Tagen

Schaffhausen, Schaffhausen, Schweiz Cpl Life Sciences Vollzeit CHF 80'000 - CHF 120'000 pro Jahr

Cpl Life Sciences are looking for a
CSV
Engineer to support the lifecycle management of computerized manufacturing systems at a pharmaceutical site in
Schaffhausen
. This is a
1-year contract
with
hybrid working
flexibility.

Key Responsibilities:

  • Ensure GMP and regulatory compliance for qualification activities of production systems.
  • Review and approve qualification lifecycle documents (e.g., URS, Impact & Risk Assessments, interface qualifications, Audit Trail reviews).
  • Review and approve procedures related to data integrity and lifecycle management of production systems.
  • Support cross-functional teams (Production, IT, Quality) to maintain compliant and reliable manufacturing systems.
  • Investigate and assess data integrity issues and software non-conformities, ensuring compliance with GMP standards.
  • Work with digital qualification tools (e.g., KNEAT) and manufacturing systems (MES, SCADA, OSI-PI, SAP, TrackWise, TruVault).

Qualifications & Skills:

  • M.Sc. in Natural Sciences, Computer Science, Engineering, or equivalent; or Bachelor's with relevant GMP experience.
  • Proven experience in
    GMP-regulated environments
    and
    CSV approach
    (ISPE standard).
  • Strong analytical and problem-solving skills.
  • Fluent in
    German
    , with basic English (B1) desirable.
  • Experience with manufacturing systems qualification and data integrity is advantageous.

If interested, please apply to the job advertisement or email for further information.

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