MV01-122325 Validation Engineer

hace 4 días


barcelona, España Veg Group A tiempo completo

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services. We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position: Validation Engineer Project Duration: 4–6 months, with potential for extension or future projects at the site. Role Summary: We are seeking a self-sufficient Validation Engineer to support a downstream biologics validation project at a cGMP manufacturing site in Puerto Rico. The ideal candidate has hands‑on experience validating downstream processes, equipment, and instruments and can manage validation activities with minimal supervision. Key Responsibilities: Execute and manage downstream validation activities (IQ/OQ/PQ, PPQ support). Validate downstream equipment including autoclaves, environmental chambers, chromatography, filtration/UF‑DF, centrifuges, formulation systems, and lyophilizers. Validate analytical and process instruments (e.g., HPLC, in‑line sensors). Author and execute validation protocols and reports in compliance with cGMP/FDA requirements. Collaborate with Engineering, Manufacturing, Quality, and Automation teams. Support deviations, change controls, and audit readiness as needed. Required Experience: Bachelor’s degree in Engineering or Life Sciences. 5+ years validation experience in biologics/pharmaceutical manufacturing. Strong hands‑on experience with downstream process and equipment validation. Ability to work on‑site and operate independently. Excellent documentation and communication skills. Preferred: Prior support of commercial manufacturing or PPQ. Availability for project start within short notice. #J-18808-Ljbffr



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