Validation Engineer
Job in
Frederick, Frederick County, Maryland, 21701, USA
Listed on 2026-05-31
Listing for:
Novozen Healthcare LLC
Full Time
position Listed on 2026-05-31
Job specializations:
-
Engineering
Biomedical Engineer, Quality Engineering, Pharma Engineer -
Quality Assurance - QA/QC
Quality Engineering
Job Description & How to Apply Below
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
- 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
- Experience supporting facility expansions or commercialization projects
- Background in biotech or medical device industry
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