6441 - CSV Engineer / Validation Engineer

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

• →Build and maintain document trackers covering system requirements, SLIA/SCA/BCA, DQ, QRA, ERES/data integrity, QP, configuration specifications, traceability matrices, commissioning documents, IOQ/PQ, QSR, green tag, and blue tag
• →Coordinate document templates, table-of-contents reviews, formal routing, comment incorporation, approval readiness, and final retrieval/closeout packages
• →Maintain distribution list, team roster, meeting minutes, action items, and document status dashboards for PM use
• →Track gaps between construction turnover packages, vendor documentation, commissioning evidence, and qualification records

• Bachelor’s Degree or equivalent required
• 5-10+ years GMP document control or validation document management
• ValGenesis strongly preferred
• Autodesk Forma or construction turnover tool experience
• GDP and electronic records fluency
• Knowledge of GMP documentation standards and electronic quality management systems
• Excellent organizational and communication skills

This role requires the ability to be on-site, full-time in Devens, MA.