About the Role
We are seeking a seasoned MES Project Manager with deep expertise in PAS-X to lead the design, deployment, and optimization of MES solutions across GMP-regulated manufacturing operations.
In this role, you will be accountable for managing complex MES programs, ensuring alignment between business needs, technical implementation, and regulatory requirements. You will serve as the primary interface between internal stakeholders, global manufacturing sites, and PAS-X implementation teams.
Key Responsibilities
* Lead end-to-end PAS-X MES project delivery including planning, design, implementation, validation, go-live, and hypercare.
* Define and manage project scope, timelines, budget, risk, and resource allocation in collaboration with stakeholders.
* Translate manufacturing process requirements into system specifications in alignment with PAS-X capabilities and best practices.
* Drive cross-functional collaboration across Manufacturing, QA, Validation, Engineering, IT/OT, and external vendors.
* Oversee system configuration, MBR design governance, interface development (e.g., ERP, LIMS, SCADA), and data migration activities.
* Ensure full compliance with GMP, GxP, CSV, GAMP5, and 21 CFR Part 11 regulations throughout the project lifecycle.
* Manage project documentation including URS, functional specs, risk assessments, validation protocols (IQ/OQ/PQ), and change controls.
* Report progress to senior leadership and steering committees, ensuring transparent communication and proactive issue resolution.
Required Qualifications
* Bachelor's or Master’s degree in Engineering, Life Sciences, Computer Science, or related field.
* 5+ years of experience in managing MES projects with a minimum of 3 years dedicated to PAS-X implementations.
* Proven track record of successful PAS-X rollouts in GMP manufacturing environments (pharma/biotech).
* In-depth knowledge of PAS-X architecture, MBR design principles, and standard modules (eBR, Equipment Management, Weigh & Dispense, etc.).
* Strong grasp of GxP, CSV, GAMP5, and data integrity principles in regulated industries.
* Experience with cross-system integration (ERP/SAP, LIMS, SCADA/DCS) and ISA-95/88 compliance.
* Excellent leadership, stakeholder management, and communication skills.
What’s in it for you?
* Opportunity to lead high-impact PAS-X projects in a globally recognized pharmaceutical environment.
* Competitive compensation and benefits.
* Work with advanced MES technology and shape the future of digital manufacturing.
* Collaborative and high-performance culture with room for career growth.