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Senior Validation Specialist
3 weeks ago
About this role:
- Lead and execute validation protocols (IQ, OQ, PQ) for facility systems and equipment.
- Develop and manage validation plans, summary reports, and change control documentation in line with site and regulatory standards.
Key Responsibilities:
- Support commissioning and qualification activities for HVAC, cleanrooms, utilities (WFI, compressed air, etc.), and facility upgrades.
- Ensure compliance with FDA, ISO 13485, EU GMP, and company quality standards.
- Coordinate with engineering, quality, and project teams to ensure timely delivery of validation deliverables.
Required Qualifications:
- Degree in Engineering, Science, or related discipline.
- Experience in a GMP-regulated environment, preferably in medical devices or pharmaceuticals.
Desirable Skills:
- Strong understanding of validation lifecycle and quality systems.
- Experience working onsite in facility or capital project environments at a pharma/biomedical site preferred.