Operational Technology MES Engineer

Thermo Fisher Scientific Inc. is a Fortune 100 company and a world leader in serving science, with annual revenue exceeding $40 billion. Our mission is to enable our customers to make the world healthier, cleaner, and safer by supporting life sciences research, analytical challenges, patient diagnostics, and laboratory efficiency.

About the role

The OT Manufacturing Lead serves as the primary IT/OT System Owner for PharmaSuite MES and AVEVA PI at the St. Louis site. The role will work closely with Global MES and Digital Center of Excellence (CoE) teams to ensure alignment with enterprise standards, templates, and deployment strategies, enabling a consistent MES platform across the network.

Responsibilities

• Act as System Owner for MES – PharmaSuite and Data platform - AVEVA PI
• Partner with Manufacturing and Quality to digitize paper-based processes
• Define and drive shop floor data strategy leveraging AVEVA PI and other data platforms
• Ensure compliance with GAMP 5 and 21 CFR Part 11
• Own system lifecycle management (upgrades, patching, obsolescence)
• Partner with Global MES teams to align site solutions with enterprise standards and reusable templates
• Lead implementation and expansion of MES capabilities including but not limited to Electronic logbooks, Equipment Workflows, Weigh & Dispense, Electronic Batch Records (eBR)
• Support data contextualization and availability for analytics, reporting, and enterprise data platforms
• Provide SME support for production issues related to MES and data systems
• Act as SME in deviation investigations, CAPAs, and inspections related to MES/data systems
• Drive training, adoption, and change management for digital manufacturing capabilities
• Lead or support capital and strategic projects related to MES and data platforms (including off-hours as required)
• Manage system vendors, integrators, and support partners
• Ensure alignment with enterprise IT/OT standards, cybersecurity, and validation requirements

Requirements

• Bachelor's degree or equivalent experience in Information Technology, Computer Science, or a related field preferred. A master’s degree or equivalent experience is a plus
• 5+ years of experience implementing Manufacturing Execution System (MES – Pharmasuite or similar) technology application solutions (solution design, install, configuration, setup, integration, and upgrades)
• Experience conducting the following activities: Business requirements gathering, fit-gap analysis, functional process design, data mapping, developing functional and technical specification documentation, system configuration, system testing (INT, UAT) and solution delivery, customer support, process document creations and review, working with onsite and offshore delivery model
• Experience using analytics and metrics to assess Manufacturing Performance and identify and quantify improvement opportunities
• Experience with enterprise system platforms, including integration of Digital Engineering Environments with Enterprise Resource Planning (ERP), Manufacturing Execution Systems (MES), or Computerized Maintenance Management System (CMMS)
• Experience working within global or enterprise system standards
• Extensive knowledge of GMP regulations in cGMP manufacturing environment
• Outstanding communication and interpersonal skills, demonstrated ability to problem solve and lead multiple projects and priorities simultaneously
• Experience with regulatory compliance and industry standards

Skills

• Work attitude that exhibits drive, creativity, collaboration, assertiveness, good judgement, decision-making and ambition
• Excellent interpersonal skills: ability to build and maintain relationships with internal and external customers
• Strong understanding of manufacturing operations and GMP processes
• Ability to translate business needs into scalable technical solutions
• Strong communication skills both written and verbal
• Ability to work on multiple projects simultaneously
• Strong proficiency in Microsoft Office Suite (Word, Excel, and Power Point)
• Effective written, interpersonal, and presentation skills

Schedule

Standard office hours (Monday–Friday, 40 hours per week). Adherence to all Good Manufacturing Practices (GMP) safety standards in an office and manufacturing environment.

Benefits

• Competitive remuneration
• Annual incentive plan bonus
• Healthcare
• Range of employee benefits

Must be legally authorized to work in the United States now and in the future, without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening.