Bachelor's degree in Engineering, Life Sciences, or a related discipline.
Experience in Equipment Validation within a GMP pharmaceutical or biopharmaceutical environment.
Hands-on experience with Kneat (Required).
Strong understanding of IQ/OQ/PQ, equipment qualification, and validation lifecycle.
Experience with Cleaning Validation (CIP, COP, SIP).
Knowledge of GMP documentation, validation protocols, and SOP development.
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).
Mindlance is a global Talent, Teams, Projects, and Workforce Solutions partner, serving leading enterprises across industries since 1999. With a global team of over 5,000 professionals, we provide scalable, AI-native solutions that enable organizations to build, optimize, and transform their workforce.
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Backed by 600+ specialized delivery experts and deep partnerships across MSP, enterprise workforce programs, and major data/cloud/software ecosystems, we also provide direct Managed SOW services with scalable teams and outcome based delivery.
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