10-15+ years in program/project management within regulated pharma/biotech settings
Proven leadership in at least one full-cycle MES implementation
Experience managing multi-site or large-scale programs exceeding $5M
Strong background with CSV lifecycle and validation documentation
Deep knowledge of GMP/GxP, data integrity, and regulatory standards
Experience in complex IT/OT integrations in manufacturing
History of financial management including budgeting and forecasting
Demonstrated capability in cross-functional leadership.
Responsibilities
Lead comprehensive MES transformation initiatives across multiple manufacturing sites from start to finish.
Oversee program scope, schedule, budget, resources, risks, and governance for MES projects.
Manage complete lifecycle of MES platforms like Werum Client-X and Siemens Opcenter.
Ensure timely completion of CSV/CSA activities and validation documentation deliverables.
Guarantee compliance of MES solutions with GMP/GxP and relevant regulatory requirements.
Direct integration between MES and other critical systems such as ERP and LIMS.
Provide strategic leadership across various departments and external partners.
Benefits
Opportunities for professional development and advancement
Collaborative work environment across diverse teams
Exposure to cutting-edge MES technologies
Engagement with high-stakes projects in the pharmaceutical sector
Potential for a positive impact on the manufacturing process and patient outcomes.
Full Job Description
Summary: We are seeking a senior, high-impact Project Manager to lead complex, multi-site MES transformation programs across a GxP-regulated pharmaceutical manufacturing network.This role is accountable for end-to-end delivery of MES platforms (e.g., Client-X, Pharma Suite, OpsCenter) including deployment, integration, validation (CSV), and operationalization at scale. The Project Manager operates with full ownership of scope, financials, governance, and regulatory readiness, ensuring all deliverables meet inspection-ready standards (GMP, GxP, 21 CFR Part 11, data integrity).
Roles & Responsibilities:
Lead end-to-end MES transformation programs across multiple pharmaceutical manufacturing sites, from strategy and design through deployment, validation, go-live, and operationalization.
Own overall program scope, schedule, budget, resources, risks, dependencies, and delivery governance for large-scale MES initiatives.
Manage full-cycle implementation of MES platforms such as Werum Client-X, Korber PharmaSuite, Siemens Opcenter, or equivalent pharmaceutical MES solutions.
Lead CSV/CSA activities and ensure validation deliverables including VP, URS, FS/DS, IQ/OQ/PQ, RTM, test scripts, deviations, and validation summary reports are completed on schedule.
Ensure MES solutions comply with GMP/GxP, 21 CFR Part 11, data integrity, electronic records/signatures, and regulatory requirements.
Direct complex IT/OT integrations between MES and systems such as ERP, LIMS, SCADA, DCS, PLC, historians, serialization, and laboratory systems.
Provide executive-level leadership across Manufacturing, Quality, Validation, IT, Engineering, Automation, and external vendors/system integrators.
Education & Experience:
10-15+ years of program/project management in regulated pharma/biotech environments
Proven leadership of at least one full-cycle MES implementation
Demonstrated ownership of multi-site or large-scale ($5M+) programs
Strong experience with CSV lifecycle and validation deliverables (VP, URS, FS/DS, IQ/OQ/PQ, RTM)
Deep familiarity with GMP/GxP, data integrity, and regulatory inspections
Experience managing complex IT/OT integrations in manufacturing environments
Track record of financial ownership (budgeting, forecasting, variance management)
Demonstrated authority in cross-functional leadership (Manufacturing, QA, Validation, IT, Engineering)
