MES Project Manager

Katalyst-Healthcares-; 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

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, 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, 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)