Senior MES Transformation Lead - Multi-Site GMP Pharma

Creative Solutions Services, LLC; Greenville (NC); On-site; USD 140,000 - 210,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a senior Project Manager to lead large-scale MES transformation programs across a multi-site pharma network. You will own scope, schedule, budget, and governance while directing end-to-end MES deployments with CSV validation and regulatory readiness.

The role requires extensive experience in GMP/GxP environments, cross-functional leadership across Manufacturing, QA, Validation, IT, and Engineering, plus strong vendor management and IT/OT integration

Qualifications

• 10–15+ years of program/project management in regulated pharma/biotech environments.
• Proven leadership of at least one full-cycle MES implementation.
• Experience managing 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)

Responsibilities

• Lead end-to-end MES transformation programs across multiple pharmaceutical 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, Körber 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, and external vendors/system integrators.

Skills

Program management

GxP compliance

CSV validation

Cross-functional leadership

Budget management

Regulatory readiness

Tools

Werum Client-X

Körber PharmaSuite

Siemens Opcenter

ERP systems

LIMS

SCADA

Job description

Creative Solutions Services, LLC is seeking a senior Project Manager to lead large-scale MES transformation programs across a multi-site pharma network. You will own scope, schedule, budget, and governance while directing end-to-end MES deployments with CSV validation and regulatory readiness.

The role requires extensive experience in GMP/GxP environments, cross-functional leadership across Manufacturing, QA, Validation, IT, and Engineering, plus strong vendor management and IT/OT integration