Senior IT Project Manager - SAP MES in Pharma

Fusion Consulting•Houston, TX

About The Position

We are seeking a Senior IT Project Manager to lead the implementation and rollout of a Manufacturing Execution System (MODA ES) with a focus 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.

Requirements

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
Familiarity with 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

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

Benefits

Invest in Your Learning: Access annual budget for professional development.
Grow Your Skills: Join regular workshops and trainings to strengthen technical and soft skills.
Advance Continuously: Build the mindset, confidence, and capabilities to grow your career on your terms.
Shape an Inclusive Culture: Thrive in a workplace where your individuality is valued, and your voice drives meaningful change.
Earn What You’re Worth: Receive a competitive salary and benefits package that reflects your impact.
Refer Talent: Get rewarded for recommending new hires through our referral program.
Stay Rewarded: Access loyalty-based benefits starting from your third year via the Unity Scheme.
Navigate Global Moves: Get help with visas, permits, and international assignments.
Benefit Locally: Enjoy perks tailored to your country of residence.
Collaborate Globally: Work in a diverse, inclusive culture where global teamwork drives success