MES Change Specialist

MES Change Specialist – Process & Compliance (Manufacturing)

Join our Process & Compliance team supporting a highly automated pharmaceutical manufacturing facility. In this role, you’ll drive MES recipe/workflow design, testing, validation, and change management to ensure compliant, efficient electronic batch record operations across HTO.

What You’ll Do

• Lead user requirement gathering and translate operational needs into MES recipe/workflow requirements
• Own CSV activities: requirements, test script authoring, CV/FV execution, and deviation management
• Troubleshoot mechanical/automation issues and support MES-related investigations
• Build, test, validate, and maintain MES changes through the full change‑management lifecycle
• Draft and execute test plans for new or modified MES recipes
• Support MES components of site initiatives (capital projects, tech transfers, DS/DP changes, launches)
• Provide audit support, demos, and responses for MES-related regulatory topics
• Identify efficiency improvements using system performance data and analytics
• Collaborate cross-functionally with Manufacturing, P&C, IT/OT, Master Data, and Quality

What You Bring

• Bachelor’s degree + 3–5 years MES/EBR/computerized systems experience in regulated manufacturing (or Master’s degree)
• Hands-on experience with computerized system construction, testing, and validation (CSV/CSA, GAMP)
• Strong background in electronic change management systems (TrackWise, Veeva, etc.)
• Understanding of SAP, MES, PLCs, HMIs, and automation systems
• Experience with sterile manufacturing processes (prep, filling, inspection, packaging)
• Ability to own changes from initiation through closure
• Preferred: Rockwell troubleshooting experience; prior EBR/MES deployment project experience