Senior IT Project Manager MES (Manufacturing Execution System)

Position: Senior IT Project Manager MES (Manufacturing Execution System)

Domain: Pharma

Location: Houston Texas 2-3 days onsite requirement per week not negotiable. (Must be - Houston Local- Travel costs are not paid by the client)

Duration: 12 months

Visa: H1B

Rate: DOE

Send ONLY 1 best qualified.

***MUST BE LOCAL TO HOUSTON/TX****

• Note#1 This is an onsite requirement, and the skillset,
  • • • • • • • • there are lots of people who managed big SAP S4 Hana projects but not MES projects
• Note#2 The experience around MES and MES integration is the primary focus. SAP is secondary.

SKILLS MATRIX:

Job Description

Senior IT Project Manager to lead the implementation and rollout of a Manufacturing Execution System (MODA ES), focused on

Electronic Batch Record (EBR) capabilities in a regulated pharmaceutical manufacturing environment.

This role will drive the digitalization of batch processes, ensuring seamless integration between manufacturing, quality,

and IT systems, while maintaining full compliance with GxP and regulatory requirements.

Key Responsibilities:

• Lead end-to-end delivery of MODA ES EBR implementation and rollout
• Coordinate across Manufacturing, Quality, IT, and Automation teams
• Ensure alignment with GxP, data integrity (ALCOA+), and validation standards
• Manage integration with systems such as MES, SAP, LIMS, and automation platforms
• Oversee URS, validation planning (CSV/CSA), testing (IQ/OQ/PQ), and release readiness

• Drive process standardization and digital transformation of batch records
• Manage vendors and system integrators delivering MODA ES solutions
• Track project scope, timelines, risks, and dependencies
• Lead steering committees and provide executive reporting
• Ensure smooth cutover, hypercare, and handover to operations

Qualifications

• 10+ years of IT Project Management experience in pharma or regulated manufacturing
• Proven experience delivering EBR / MES / digital manufacturing solutions
• Strong understanding of MODA ES or similar platforms (e.g., Werum PAS-X, Siemens Opcenter, Rockwell PharmaSuite)
• Deep knowledge of GxP, 21 CFR Part 11, Annex 11, and data integrity principles
• Experience with CSV/CSA validation methodologies
• Experienced in SAP, LIMS, and shopfloor integration
• Strong stakeholder management across business, IT, QA, and vendors
• Excellent communication and leadership skills
• PMP, Prince2, or equivalent certification
• Fluent in English