Senior CSV Engineer / Senior Validation Engineer
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 Delta V
- 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
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