Digital Manufacturing OT Lead, Technical Operations

JOB DESCRIPTION

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Laboratory Setting, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

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 Manufacturing OT Engineer within the Technical Operations team. The OT Manufacturing Lead serves as the primary Point of Contact (POC) representing Manufacturing Operations for PharmaSuite MES, AVEVA PI and digital platform implementation at the St. Louis site. The role will work closely with IT, 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. Additionally, they will work with Data Sciences, Process Engineering, Validation, MSE and Quality to digitize paper-based processes currently being used on site.

What will you do?
• Act as the Operations/Manufacturing System Owner for MES – PharmaSuite and Data platform - AVEVA PI.

- Act as Operations lead during digital platform implementation and rollout.

• Acting as the technical lead and accountable Subject Matter Expert (SME) for Manufacturing operations.
• Partner with IT, Data Sciences, Process Engineering, Validation, MSE and Quality to digitize paper-based processes
• Define and drive shop floor data strategy leveraging AVEVA PI and other data/digital platforms
• Ensure compliance with GAMP 5 and 21 CFR Part 11
• Assist with 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
• Act as SME in deviation investigations, CAPAs, and inspections related to Manufacturing and 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

•·Reviewing vendor deliverables, testing documentation, and supporting documentation for technical accuracy and completeness
• Ensure alignment with enterprise IT/OT standards, cybersecurity, and validation requirements

•·Coordinating the allocation of design and support, as appropriate

• Provide oversight and support to the Quality Change Request (Change Control) for MES Digitization implementation plan.

•·Serving as Change Owner for applicable system parent change records

•·Providing personnel and documentation support for commissioning and validation activities, as required

•·Reviewing and approving scope change requests and implementing approved changes within Manufacturing

•·Ensure compliance with Engineering Change Management (ECM) procedures and systems

•·​Support development of the User Requirements Brief (URB) and associated key project data

How will you get here?

Education
• Bachelor's degree (BS) or equivalent experience in Information Technology, Computer Science, Biology, Biochemistry or a related field preferred. A master’s degree or equivalent experience is a plus

Experience

• At least three years supervisory, team lead, or project lead experience within the pharmaceutical industry. Knowledge of manufacturing processes and IT experience is a plus.

• 5+ years of experience implementing or working with Manufacturing Execution System (MES – Pharmasuite or similar) technology application solutions

• Experience working with or within an Upstream, Downstream, BAM manufacturing team or have drug substance/product manufacturing experience..
• Experience conducting the following activities: Business requirements gathering, fit-gap analysis, functional process design, data mapping, developing functional and technical specification documentation, system testing (INT, UAT) and training for manufacturing operators etc...
• 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, 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 (Upstream/Downstream Manufacturing & BAM) 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.