Computerized System Validation Expert

1 week geleden

Geleen, Limburg, Nederland Lonza Voltijd

At Lonza, we are seeking a highly skilled Computerized System Validation Expert to join our team. This specialized role will focus on Computerized System Validation activities and is a highly important Subject Matter Expert within the wider team.

The CSV Specialist - Life Sciences will be involved in all Computerized System Validation activities, including but not limited to: Facilities, Utilities, Validation Life Cycle, Execution, Technical Documentation, Process, GAP Analysis, Risk Assessment, among others. The validation documentation deliverables include URS, DQ, FMEA, Risk Assessments, FAT, SAT, Protocols (IQ, IOQ, OQ, PQ).

The ideal candidate will have a Validation Engineer - Lonza background and excellent understanding of good documentation practices, data integrity and ALCOA++. Knowledge of 21 CFR Parts 210, 211, 11, EU Annex 11 and GAMP 5 is also required.

Key responsibilities include:

  • Generating and executing (as applicable) User Requirements, Design Specification, Functional Specification and Traceability Matrix.
  • Producing Validation Plans, IQ/OQ/PQ Protocols, test scripts, and SOPs as required to meet 21 CFR Parts 210, 211, 11, EU Annex 11, and GAMP requirements among others.
  • Developing CSV Gap Assessments and Remediation Plans with an understanding of applying risk management principles.
  • Supporting regulatory and client audits as CSV subject matter expert.
  • Working to identify efficiencies in the CSV program approach and apply lessons learned.
  • Performing assigned Quality Systems activities including Document Management system, Change Control, Non Conformities, and CAPA's.
  • Writing and/or revising procedures applicable to CSV activities.

Key requirements include:

  • Bachelor degree or equivalent in a relevant subject area.
  • Demonstrable experience within CSV in a GMP environment (or similar).
  • Business-level fluency in English; other languages are nice to have but not required.

At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

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