MES Change Control & Validation Specialist

MES Change Control & Validation SpecialistJob Summary:Seeking an MES Change Control & Validation Specialist to support pharmaceutical manufacturing operations. The role focuses on MES change management, computerized system validation (CSV), electronic batch records, testing, and regulatory compliance.

Key Responsibilities

Manage MES changes from requirements gathering through testing, validation, implementation, and closure.Develop and execute test scripts and protocols for MES recipes and workflows.Investigate MES defects, deviations, and exceptions; drive corrective actions.Coordinate change controls across Manufacturing, Quality, IT/OT, and Master Data teams.Support manufacturing automation troubleshooting, audits, tech transfers, and product launches.Required Qualifications:Bachelor’s degree with 3–5 years of MES, EBR, or computerized systems experience in regulated manufacturing, or a relevant master’s degree.Hands-on manufacturing experience is required.Experience with change management systems such as Veeva or TrackWise.Knowledge of CSV/CSA, GAMP, MES, SAP, PLCs, and HMIs.Strong technical documentation, testing, validation, and troubleshooting skills.Sterile pharmaceutical manufacturing, Rockwell automation troubleshooting, and MES/EBR implementation experience.