About the Role: We are seeking a skilled Validation Engineer to lead and execute facility-related validation activities for capital and project initiatives at a medical device manufacturing site.
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Key Responsibilities:
* 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 quality standards.
* Coordinate with engineering, quality, and project teams to ensure timely delivery of validation deliverables.
* 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.
Job Summary:
We are looking for a detail-oriented and organized individual to join our team as a Validation Engineer. The ideal candidate will have hands-on experience in facility/equipment qualification and a solid understanding of regulatory requirements.