Senior Specialist, Validation Engineer - CSV

Role: Senior Validation Engineer specializing in Computer System Validation (CSV) for biopharmaceutical manufacturing systems, supporting both clinical and commercial production. Responsibilities: execute validation efforts on GMP manufacturing systems (Process Control System DeltaV and MES Syncade), manage test protocols, resolve issues, and approve configuration change reports; assess validation work arising from change controls, projects, and revalidations; provide validation support to cross-functional teams and ensure compliance with industry and regulatory standards (FDA, EU). Requirements: B.S. in engineering (chemical preferred) or related field; 2+ years in biopharmaceutical validation, especially with process automation, DCS, or PLC-based systems; knowledge of cGMP, SOPs, and regulatory guidelines; project management and technical writing skills. Preferred: experience with large-scale distributed control systems, lean principles; strong communication skills. High-Value: validation of automated GMP systems in biologics manufacturing, compliance with FDA/EU regulations, cGMP environment, supporting clinical and commercial manufacturing. WorkSetup: based in Devens, MA, with a focus on validation within a highly automated biologics manufacturing facility.