top of page
Validation Engineer
- Overview
We are seeking experienced Validation Engineers to support cGMP-regulated pharmaceutical, biotechnology, and medical device manufacturing facilities. This is a hands-on, “doer” role focused on executing validation activities across equipment, utilities, processes, and computerized systems.
Key Responsibilities
Execute validation lifecycle activities including IQ, OQ, PQ protocols
Develop, review, and approve validation documentation (protocols, reports, deviations)
Perform equipment, utility, facility, and/or process validation
Support commissioning and qualification (CQV) efforts for new and existing systems
Ensure compliance with FDA, cGMP, and regulatory requirements
Collaborate with engineering, quality, manufacturing, and automation teams
Investigate and resolve deviations, CAPAs, and change controls
Support audits and inspections as needed
Qualifications
Bachelor’s degree in Engineering or related technical field
3+ years of validation experience in a cGMP environment
Strong knowledge of validation principles (IQ/OQ/PQ)
Experience with one or more of the following:
Equipment / Process Validation
Utilities (HVAC, Clean Utilities, etc.)
Computer System Validation (CSV)
Familiarity with 21 CFR Part 11, GAMP, and FDA guidelines
Strong documentation and communication skills
Preferred Experience
Background in pharmaceutical, biotech, or medical device industries
Experience supporting new facility builds, expansions, or remediation projects
Exposure to automation systems, MES, or DeltaV is a plus
What This Role Offers
Long-term project opportunities in regulated environments
Exposure to high-impact manufacturing and validation initiatives
Ability to work on-site with cross-functional teams driving execution
bottom of page