Digital Manufacturing OT Lead, Technical Operations

Thermo Fisher Scientific seeks a Digital Manufacturing OT Lead to serve as the primary operations contact for MES and digital platform implementations at its St. Louis facility. The role bridges manufacturing operations with IT and engineering teams to digitize processes, ensure regulatory compliance, and standardize manufacturing execution systems across the enterprise.

Responsibilities

• Serve as Manufacturing System Owner for PharmaSuite MES and AVEVA PI data platform
• Lead digitization of paper-based manufacturing processes with IT, Process Engineering, and Quality teams
• Define shop floor data strategy and oversee implementation of MES capabilities including electronic batch records
• Ensure compliance with regulatory standards and lead deviation investigations, CAPAs, and inspections
• Drive training, adoption, and change management for digital manufacturing capabilities across the facility

Requirements

• Bachelor's degree in IT, Computer Science, Biology, Biochemistry, or related field; master's degree preferred
• 5+ years implementing or supporting MES technology solutions such as PharmaSuite
• 3+ years supervisory, team lead, or project leadership experience in pharmaceutical manufacturing
• Experience with upstream/downstream or drug substance/product manufacturing operations
• Knowledge of GMP regulations, GAMP 5, and 21 CFR Part 11 compliance requirements
• Proficiency in business requirements gathering, fit-gap analysis, system testing, and training delivery
• Experience with enterprise platforms including ERP, MES, and CMMS integration