Validation Project Manager
3 weeks ago
About GerTEK: GerTEK is an engineering consultancy company specialising in project management, talent solutions and commissioning qualification and validation services.
We partner with many of the world's largest life science & have multiple projects that we support.
Role: Validation Engineer We are seeking a Validation Engineer to support and manage facility-related validation activities for capital and project initiatives at our medical device manufacturing site.
The ideal candidate will have hands-on experience in facility/equipment qualification, a solid understanding of regulatory requirements, and the ability to work collaboratively with cross-functional teams in a GMP-regulated environment.
Key Responsibilities: 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.
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.
Participate in risk assessments and gap analyses for facility modifications and equipment installations.
Maintain validation documentation in accordance with internal procedures and audit readiness requirements.
Qualifications: Degree in Engineering, Science, or related discipline.
Experience in a GMP-regulated environment, preferably in medical devices or pharmaceuticals.
Strong understanding of validation lifecycle and quality systems.
Experience working onsite in facility or capital project environments at a pharma/biomedical site preferred To start the process click the Continue to Application or Login/Register to apply button below.
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