Senior MES Project Manager - in Pharma - (2-3 days onsite in Houston, TX, USA)

Job Description

Job Description

Company Description

Transforming Life Science Consulting Worldwide.

Fusion Consulting is a globally leading Business and IT boutique consultancy specialized in the Life Sciences industry, partnering with leading companies in pharma, healthcare, and animal health.

With over 450 employees and 25 offices worldwide, our mission is to revolutionize our clients' business transformation challenges and set new industry standards through innovative solutions.

Focused on S/4HANA, Data & Cloud, and innovative technologies, Fusion Consulting brings unparalleled expertise and commitment to excellence to every project we undertake.

Grounded in our commitment to fast and intelligent decision-making, our client-first and open-hearted approach defines our ethos. With unwavering support and an entrepreneurial spirit, our global teamwork transcends boundaries and turns shared visions into reality.

At Fusion, we unite entrepreneurial minds from around the globe to develop and implement game-changing solutions that build lasting relationships with our clients.

Job Description

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.

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
• 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

Additional Information

WHY YOU SHOULD JOIN FUSION:

At Fusion, you’ll join a diverse team of talented professionals from around the world, united by a passion for delivering impactful digital transformation in the life sciences industry. You’ll be part of a flat-structured, collaborative organization where decisions are made efficiently, and your expertise directly shapes client outcomes.

You’ll work alongside experienced consultants on complex, meaningful projects that demand both precision and innovation. Our culture emphasizes continuous learning, open knowledge sharing, and cross-functional teamwork—empowering you to grow both professionally and personally.

Joining Fusion means becoming part of a company that:

• Builds strong, trusted partnerships with clients , delivering tailored solutions that create real business value.
• Drives delivery excellence , holding ourselves accountable for the quality and impact of every outcome.
• Encourages entrepreneurial thinking , empowering you to take initiative, solve problems, and lead change.
• Operates with a truly global mindset , where diverse perspectives, cultures, and collaboration fuel our success.

WHAT WE OFFER - FUSION BENEFITS

We’ve designed our benefits to support your growth, well-being, and global mobility.

Growth & Development

• 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.

Recognition & Reward

• 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.

Global Mobility & Local Support

• 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