Operational Technology MES Engineer

Work Schedule

Environmental Conditions

Job Description

When youre part of the team at Thermo Fisher Scientific youll 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 youll 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 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
Bachelors degree or equivalent experience in Information Technology Computer Science or a related field preferred. A masters 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.