MES Project Manager

Katalyst CRO; Greenville (NC); On-site; USD 140,000 - 190,000; Full time

Job summary

Katalyst CRO is seeking a senior, high-impact Project Manager to lead complex, multi-site MES transformation programs within a GxP-regulated pharma network. You will own end-to-end delivery of MES platforms (Werum Client-X, PharmaSuite, Opcenter), including deployment, validation (CSV), and operationalization at scale.

Role requires full ownership of scope, schedule, budget, risks, and governance with strong cross-functional leadership across Manufacturing, Quality, Validation, IT, and external

Qualifications

• 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).

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.

Skills

Project management

Regulatory compliance

Leadership

CSV/Validation

Budgeting & forecasting

Vendor management

Education

Bachelor's degree in a related field

Tools

Werum Client-X

Körber PharmaSuite

Siemens Opcenter

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).

• 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.

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)