Digital Manufacturing OT Lead, Technical Operations

Work Schedule

Environmental Conditions

Job Description

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 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 - AVEVAPI.

- 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
Bachelors degree (BS) or equivalent experience in Information Technology Computer Science Biology Biochemistry or a related field preferred. A masters 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.