Computer System Validation Engineer

Vor 5 Tagen

Schaffhausen, Schaffhausen, Schweiz CTC Resourcing Solutions Vollzeit CHF 80'000 - CHF 120'000 pro Jahr

CTC is a specialized search and recruitment partner for the Life Sciences industry, serving clients and candidates since 1997. We enable careers by connecting talented professionals with meaningful opportunities, and we support our clients in engaging, retaining, and developing the right talent when needed.

Our client, a dynamic global bio-pharmaceutical and Medtech company headquartered in Switzerland, covering multiple therapeutic areas, is looking for a
QA Quality Engineer/CSV
on an initial
12-months
contract
based in
Schaffhausen, Switzerland.

As a Quality Engineer/CSV,
you will be responsible for the lifecycle management of computerized systems in the manufacturing area, ensure data integrity, and maintain compliance with CSV and governance standards.

QA Quality Engineer/CSV

Main Responsibilities:

Manufacturing systems & Software Qualification:

  • Ensure GMP and regulatory compliance for qualification activities of production systems
  • Review and approve qualification lifecycle documents (e.g., Impact & Risk Assessments, URS, interface qualification, Audit Trail review) for production systems
  • Review and approve procedures (WIs, SOPs) related to data integrity and lifecycle management of production systems
  • KNEAT experience (digital qualification tool)

Data Integrity & Governance:

  • Review and approve requirements for new software solutions and analyze data and process flows within the production environment
  • Review and ensure strategies for security, backup, and recovery for computerized production systems (e.g., databases)
  • Approve archiving or migration of legacy system data as part of lifecycle management
  • Investigate and assess data integrity issues and software non-conformities (NC, CAPA) in compliance with GMP and regulatory standards

Cross-functional Collaboration:

  • Support and coordinate teams (e.g., Production, IT, Quality Assurance) in the area of complaints to ensure seamless integration of production systems and data workflows.
  • Ensure structured communication on requirements, system changes, and troubleshooting to improve interaction between teams.

Qualifications and Experience:

  • Relevant working/residency permit or Swiss/EU-Citizenship required
  • M.Sc. in Natural Sciences, Computer Science, Engineering, or related field (Alternatively: Bachelor's degree or equivalent vocational training combined with several years of relevant experience in a GMP environment)
  • Proven work experience in GMP-regulated environments (preferably Quality Control)
  • Strong analytical and problem-solving skills
  • Experience with CSV qualification approach (ISPE standard)
  • Fluent in German and basic spoken English skills (B1 or above desirable)

Preferred Skills & Technologies (advantageous but not required):

  • Hands-on familiarity with manufacturing systems qualification, CSV, SCADA, or virtualization
  • Experience with MES, OSI-PI, SAP, TrackWise, or TruVault
  • Ability to convey technical material to non-specialists

Would you like to learn more about CTC and the opportunity outlined? Please, get in contact with us: you may either use the 'apply now' button, or write an email to us, or reach out to us on the phone.

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