Validation Engineering
Novozen Healthcare LLC
Job Summary We are seeking a Validation Engineer to support validation and lifecycle management of GMP equipment within a regulated environment. This role requires a hands-on professional who can own both documentation and execution, working closely with Quality, Operations, and Validation teams to ensure equipment remains in a validated and inspection-ready state.
Key Responsibilities Author, review, and execute validation deliverables including URS, IQ/OQ/PQ, RTM, and summary reports
Support full equipment validation lifecycle in a GMP-regulated environment
Perform protocol pre-reviews, execution, and ensure compliance with validation standards
Investigate deviations, discrepancies, and CAPAs related to validation activities
Act as an onsite point of contact for validation contractors and cross-functional teams
Collaborate with QA, Operations, and Engineering for process improvements and updates
Maintain validated state of equipment through periodic reviews and post-maintenance validation
Support facility expansion, commercialization, and system upgrades
Manage and track equipment using Blue Mountain RAM system
Required Qualifications Strong experience with equipment validation lifecycle (URS, IQ/OQ/PQ, RTM, reports)
5+ years of hands-on experience in GMP-regulated environments (pharma/biotech/medical device)
Experience supporting deviations, investigations, and protocol discrepancies
Ability to work cross-functionally with QA, Operations, and Validation teams
Strong documentation, review, and compliance skills
Experience with Blue Mountain RAM system (must-have)
Bachelor’s degree in Engineering, Life Sciences, or related field
Preferred Qualifications Experience supporting facility expansions or commercialization projects
Background in biotech or medical device industry
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Vacancy posted 2 days ago
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