Posted 20 July, 2026
Cleaning Validation specialist
Mindlance
Portsmouth, NH, US
Full Time
Job Description
We are seeking a QA Validation Specialist III to support equipment validation and cleaning validation activities within a GMP biopharmaceutical manufacturing environment. The ideal candidate will have hands-on experience with Kneat, equipment qualification, validation lifecycle documentation, and GMP quality systems. Key Responsibilities Execute equipment validation activities, including IQ, OQ, PQ, and equipment requalification. Develop and maintain validation protocols, reports, and supporting documentation using Kneat. Support cleaning validation activities, including CIP, COP, SIP, Media Hold, and Media Fill processes. Perform validation for manufacturing equipment such as Autoclaves, Parts Washers, Controlled Storage Equipment, and Single-Use Systems. Conduct temperature mapping activities (experience with Ellab is a plus). Review and support SOPs, validation protocols, change controls, deviations, and CAPAs. Maintain equipment in a validated state through validation maintenance and periodic requalification. Support qualification of clean utilities and controlled environments. Collaborate with Manufacturing, Quality Control, Engineering, and Quality Assurance teams to execute validation activities. Perform Quality Systems activities within TrackWise and Document Management Systems (DMS).
