Work Schedule
Standard Office Hours (40/wk)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office
Work Schedule
Standard (Mon-Fri)
How will you make an impact?
Embrace an amazing opportunity to join Thermo Fisher Scientific Inc. in St. Louis, MO as our OT Engineer. 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.
What will you do?
• 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
How will you get here?
Education
• 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
Experience
• At least three years supervisory/ team lead experience within the pharmaceutical industry in manufacturing or lab related IT roles
• 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), to new a few
• Experience working within global or enterprise system standards
• Extensive knowledge of GMP regulations in cGMP manufacturing environment
• Outstanding communication and interpersonal skills, with the ability to lead and encourage teams.
• Demonstrated ability to problem solve and lead multiple projects and priorities simultaneously.
• Experience with regulatory compliance and industry standards.
Knowledge, Skills, Abilities
• 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; highly functioning team leader and team member in a multi-skilled, dynamic business environment.
• 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.
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!
Other
Relocation assistance is not provided.
