Ampstek ยท 1 week ago
MES Project Manager (Only USC on W2)
United States
Contract
Remote
Senior Level, Lead/Staff
10+ years expAmpstek is seeking an MES Project Manager to lead the implementation of the Manufacturing Execution System across multiple manufacturing sites. This role involves managing project scope, budget, and timelines while ensuring alignment with global standards and local operational needs.
IT Management
No H1B
U.S. Citizen OnlyHiring Manager
David Wilfred
Responsibilities
Lead end-to-end MES project lifecycle at assigned site(s): initiation, planning, execution, validation, go-live, hyper care
Develop and maintain project plans, risk registers, and status reports
Manage project scope, budget, and schedule, escalating issues as needed
Coordinate with the global program team to ensure alignment with global template and governance
Act as liaison between site leadership, operators, QA, engineering, IT, and the MES team
Facilitate workshops, requirements gathering, and fit-gap analysis
Drive alignment with site leadership on change impacts, resource needs, and project goals
Ensure MES system design aligns with global standards and local regulatory requirements (e.g., FDA 21 CFR Part 11, EU Annex 11, GMP)
Coordinate integration with ERP (SAP), LIMS, RedZone (OEE), and automation systems (PLC/SCADA)
Oversee system configuration, testing, validation (CSV), and data migration
Implement OCM activities: communication, engagement, and end-user adoption
Ensure delivery of role-based training for operators, QA, and IT staff
Support creation of site-specific SOPs aligned to MES processes
Ensure system validation and documentation meet regulatory and internal QA requirements
Support QA in review by exception and digital batch record adoption
Ensure audit-readiness of MES records and processes
Oversee hyper care support period post-deployment
Capture lessons learned and feed back into a global template for future rollouts
Drive continuous improvement in MES usage, data quality, and compliance
Qualification
Required
10+ years of experience in project management
Experience leading the implementation of Manufacturing Execution Systems (MES)
Ability to manage cross-functional stakeholders (Production, QA, Engineering, Supply Chain, IT/OT)
Experience in developing and maintaining project plans, risk registers, and status reports
Ability to manage project scope, budget, and schedule
Experience coordinating with global program teams
Ability to act as a liaison between site leadership, operators, QA, engineering, IT, and the MES team
Experience facilitating workshops, requirements gathering, and fit-gap analysis
Ability to ensure MES system design aligns with global standards and local regulatory requirements (e.g., FDA 21 CFR Part 11, EU Annex 11, GMP)
Experience coordinating integration with ERP (SAP), LIMS, RedZone (OEE), and automation systems (PLC/SCADA)
Experience overseeing system configuration, testing, validation (CSV), and data migration
Experience implementing organizational change management activities
Ability to ensure delivery of role-based training for operators, QA, and IT staff
Experience supporting the creation of site-specific SOPs aligned to MES processes
Ability to ensure system validation and documentation meet regulatory and internal QA requirements
Experience supporting QA in review by exception and digital batch record adoption
Ability to ensure audit-readiness of MES records and processes
Experience overseeing hyper care support period post-deployment
Ability to capture lessons learned and feed back into a global template for future rollouts
Experience driving continuous improvement in MES usage, data quality, and compliance
Company
Ampstek
Ampstek supplies thousands of tech and digital professionals annually to a range of clients through its offices which spread across in 42 countries.
1001-5000 employees
Funding
Current Stage
Late StageLeadership Team
Rekha Pathy
CEO
Company data provided by crunchbase