MES CSV Engineer

We are seeking an experienced MES CSV Engineer to lead validation and compliance for a major digital manufacturing rollout. Working within a regulated pharmaceutical environment, you will partner with engineering, QA, and operations to deliver a compliant, production-ready system.

Key Responsibilities:

• Manage end-to-end CSV activities across the MES implementation lifecycle in alignment with GMP, GxP, and regulatory standards.
• Author, review, and execute validation plans, protocols, and test scripts while maintaining thorough compliance records.
• Identify, log, and collaborate with technical teams to resolve testing discrepancies and validation deviations.
• Partner closely with MES engineers, IT, QA, and site operations to verify system readiness prior to go-live.

Requirements:

• BS degree with 4+ years of experience in Computer Systems Validation (CSV) within a regulated manufacturing setting.
• Background in pharmaceutical, biopharma, or life sciences manufacturing.
• Hands-on validation experience supporting Manufacturing Execution Systems (MES).
• Direct experience with enterprise MES platforms (e.g., Werum PAS-X, Emerson Syncade, Siemens Opcenter).
• Deep familiarity with validation lifecycle documentation, test execution, and compliance standards.