Isolator Validation Engineer

Isolator Validation Engineer at Meet Life Sciences Isolator Validation Engineer at Meet Life Sciences in Research Triangle Park, North Carolina Posted in 2 days ago.

Type:

full-time

Job Description:

Job Summary The Isolator Validation / Qualification Engineer is a hands-on role responsible for executing and overseeing qualification activities within a GMP cleanroom manufacturing environment. This position serves as the on-floor validation lead, coordinating cross-functional teams, supporting vendor-led efforts, and ensuring validation deliverables are completed accurately and on schedule. The role requires strong technical expertise in isolator systems, aseptic processing, and validation practices, along with the ability to drive projects to completion. Responsibilities Lead and support isolator qualification activities, including

IQ/OQ/PQ

phases Serve as the on-floor point of contact during vendor-led qualification and testing activities Author, review, and approve validation documentation, including: Smoke study protocols, Qualification protocols and reports, Deviations, investigations, and CAPAs, Validation Summary Reports (VSRs) Oversee execution of validation studies to ensure compliance with GMP and internal standards Coordinate with Manufacturing teams to support protocol execution and resource planning Provide direction and oversight to personnel executing validation activities Support and/or review Vaporized Hydrogen Peroxide (VHP) cycle development for isolator decontamination Track, manage, and resolve protocol deviations and incidents Drive project timelines, ensuring milestones and deliverables are met Organize and coordinate cross-functional teams, including internal stakeholders and external vendors Communicate project status, risks, and mitigation plans to leadership Qualifications Bachelor's degree in Engineering, Life Sciences, or a related field (or equivalent experience) Proven experience in isolator qualification within a GMP-regulated environment Strong knowledge of cleanroom operations and aseptic manufacturing processes Experience authoring and reviewing validation documentation (protocols, deviations, VSRs) Demonstrated ability to oversee and guide execution performed by manufacturing teams or vendors Familiarity with VHP cycle development and decontamination processes