Validation and Compliance Engineer in Pharmaceutical Production

il y a 4 jours


Antwerpen, Flandre, Belgique Optimus Life Sciences Temps plein

Job Description:

Optimus Life Sciences is looking for a highly skilled CSV (Computer Systems Validation) Validation Engineer to join our team. As a key member of our project, you will be responsible for validating pharmaceutical machinery used in tablet production.

Your Key Responsibilities:

  • Validate computer systems used in pharmaceutical production, ensuring compliance with GxP regulations.
  • Develop and execute validation protocols (IQ, OQ, PQ) and ensure all documentation meets GxP and regulatory compliance standards.
  • Collaborate with cross-functional teams to ensure that systems are designed, implemented, and maintained in compliance with 21 CFR Part 11 and EU Annex 11.

What You'll Need:

  • 3+ years of experience in CSV validation within the pharmaceutical or biotechnology industries.
  • Proficient in computer systems validation (CSV) processes, including design, execution, and documentation of validation protocols such as IQ (Installation Qualification), OQ (Operational Qualification), and PQ (Performance Qualification).
  • Knowledge of GxP regulations, 21 CFR Part 11, EU Annex 11, and industry standards for pharmaceutical systems.


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