Senior Validation Specialist
7 days ago
Catalyx is a leading organization in the field of computerized systems validation. We are currently seeking a skilled CSV Engineer to join our team and work on various projects across different sites.
Job DescriptionThe primary responsibility of this role will be to ensure the ongoing validation compliance of computerized equipment and systems in sterile manufacturing environments.
- Lead and support validation activities for new and existing computerized equipment and control systems.
- Develop and maintain validation documentation (protocols/reports) and assist with the execution of validation protocols.
- Participate in the change control process, advising on CSV matters.
- Contribute to the development and execution of DQ, IQ, OQ, and PQ protocols.
- Evaluate and ensure all projects are delivered in line with cGMP, Health Safety, environmental, and regulatory standards.
- Design, implement, and execute validation studies for manufacturing and control systems, including critical utilities and facilities.
- Degree in Science (Chemistry, Microbiology, or Pharmacy preferred) or Engineering (Chemical/Mechanical/Electrical).
- Post-graduate qualification desirable.
- Minimum 3–5 years' experience in a healthcare manufacturing environment, ideally within the pharmaceutical sector.
- 2–3 years' experience in a validation or CSV role.
- Project management experience.
- Strong technical knowledge of pharmaceutical operations.
- Familiarity with GAMP, ISPE Baseline Guides, and quality/compliance regulations.
- Strong analytical skills, with ability to troubleshoot complex issues in validation projects.
- Effective communication and facilitation skills, with ability to influence and work across multifunctional teams.
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