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Senior CSV Engineer / Senior Validation Engineer

Devens, MA

Validation Engineer Responsibilities:

• Lead and execute end-to-end CSV activities for automation changes, including development and approval of validation plans, risk assessments, traceability matrices, IQ/OQ protocols, and summary reports
• Support and drive User Acceptance Testing (UAT) to qualify DeltaV automation updates tied to NPI, ensuring all recipe, sequencing, and flow path changes meet functional and regulatory requirements
• Validate and document updates to batch recipes, sequencing logic, control modules, and process flow paths within the Emerson DeltaV platform
• Partner cross-functionally with Automation, Process Engineering, Manufacturing, and QA teams to ensure timely execution of validation activities and resolution of deviations or test discrepancies
• Ensure compliance with GxP, 21 CFR Part 11, and risk-based validation methodologies while supporting change control and release of qualified automation updates to production

Requirements:

• Bachelor's Degree or equivalent required (STEM degree, Biomedical Engineering, Chemical Engineering preferred)
• 5+ years of industry experience
• Strong experience with DeltaV
• Strong understanding of GxP requirements and 21 CFR Part 11 compliance
• Familiarity with validation lifecycle documentation and electronic protocol management systems
• Strong problem-solving and critical thinking skills
• Excellent organizational and time management skills