Operational Technology MES Engineer

ThermoFisher Scientific; St. Louis (MO); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Healthcare

Annual bonus

Career development

Job summary

Thermo Fisher Scientific is seeking an OT Engineer in St. Louis, MO to serve as the primary IT/OT System Owner for PharmaSuite MES and AVEVA PI. You will collaborate with Global MES and Digital CoE teams to align with enterprise standards and reusable templates across the site.

The role includes implementing MES capabilities, ensuring GAMP 5 and 21 CFR Part 11 compliance, and driving digital manufacturing initiatives while coordinating with manufacturing, quality, and IT teams.

Qualifications

• Bachelor's degree in IT/CS or related field preferred; a master's degree is a plus.
• 5+ years of experience implementing MES (PharmaSuite or similar) technology solutions.
• Extensive knowledge of GMP/cGMP regulations in manufacturing environments.

Responsibilities

• Act as System Owner for MES – PharmaSuite and AVEVA PI.
• Digitize paper-based processes with Manufacturing and Quality teams.
• 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 including upgrades and obsolescence.
• Lead expansion of MES capabilities (Electronic logbooks, Weigh & Dispense, eBR).
• Coordinate with Global MES teams to align with enterprise standards.

Skills

Strong communication

Problem solving

Leadership

Collaborative

GMP knowledge

Education

Bachelor's degree in IT/CS or related field

Master's degree a plus

Tools

PharmaSuite MES

AVEVA PI

ERP integration

Job description

Work Schedule

Standard Office Hours (40/wk)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

Job Description

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have real-world impact, and you’ll be supported in achieving your career goals.

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. Whether our customers are accelerating life sciences research, solving sophisticated analytical challenges, improving patient diagnostics and therapies, or growing efficiency in their laboratories, we are here to support them.

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

• 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,
• 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.
• 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.

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.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.