Digital Manufacturing OT Lead, Technical Operations

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