Operational Technology MES Engineer

Thermo Fisher Scientific • St. Louis, MO

2d • Onsite

About The Position

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.

Requirements

• 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.
• 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.

Nice To Haves

• 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

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

Benefits

• competitive remuneration
• annual incentive plan bonus
• healthcare
• a range of employee benefits
• employment with an innovative, forward-thinking organization
• outstanding career and development prospects
• an exciting company culture that stands for integrity, intensity, involvement, and innovation!

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree