MES Lead

Location: Richmond, VA
Work Arrangement: 100% Onsite – 5 Days a Week
Experience: 9+ Years
Job Type: Contract
Industry: Pharmaceutical / Life Sciences

Job Overview

We are seeking an experienced Lead Manufacturing Execution System (MES) Engineer to lead MES implementation, site setup, integration, and deployment activities for a pharmaceutical manufacturing client in Richmond, Virginia.

The ideal candidate will have strong experience implementing MES solutions in regulated pharmaceutical or life sciences environments, with a solid understanding of GMP, FDA 21 CFR Part 11, electronic batch records (EBR), and computer system validation (CSV).

Key Responsibilities

• Lead end-to-end MES implementation, configuration, deployment, and manufacturing site setup.

• Coordinate MES installation, commissioning, testing, and production go-live activities.

• Collaborate with manufacturing, quality assurance (QA), quality control (QC), validation, engineering, and IT teams.

• Support the design and implementation of electronic batch records, electronic work instructions, and production workflows.

• Ensure MES solutions comply with applicable cGMP requirements, FDA 21 CFR Part 11, and data integrity standards.

• Lead or coordinate computer system validation activities, including requirements traceability, risk assessments, test execution, and validation documentation.

• Integrate MES with ERP, LIMS, SCADA, PLCs, and other manufacturing systems as required.

• Manage system configuration, troubleshooting, defect resolution, and technical issue escalation.

• Coordinate Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), User Acceptance Testing (UAT), and qualification activities, as applicable.

• Manage project schedules, dependencies, risks, deliverables, and cross-functional resources.

• Support production readiness, go-live, hypercare, and post-implementation improvements.

• Maintain technical documentation and ensure systems are implemented in accordance with approved procedures.

Required Qualifications

• 9+ years of experience in MES implementation, engineering, deployment, or technical leadership.

• Proven experience delivering MES solutions in pharmaceutical, biotech, or other regulated life sciences manufacturing environments.

• Strong understanding of pharmaceutical manufacturing processes and cGMP requirements.

• Experience with electronic batch records (EBR), electronic records, and electronic signatures.

• Knowledge of FDA 21 CFR Part 11 and computer system validation (CSV).

• Experience with MES integration involving ERP and shop-floor automation systems.

• Experience with system testing, validation documentation, commissioning, and production deployment.

• Strong leadership, stakeholder management, and problem-solving skills.

• Ability to work onsite in Richmond, VA, five days per week.

Preferred Qualifications

• Experience with pharma MES platforms such as Werum PAS-X, Siemens Opcenter, Rockwell PharmaSuite, or equivalent systems.

• Knowledge of GAMP 5, ALCOA+ data integrity principles, and risk-based validation.

• Experience with SAP integration, LIMS, SCADA, PLCs, and industrial automation.

• Experience with batch manufacturing, process manufacturing, or pharmaceutical packaging operations.

• Previous experience leading MES implementation teams and coordinating QA/validation stakeholders.

Ideal Candidate

A senior MES technical lead with pharmaceutical manufacturing experience who can drive site setup and end-to-end MES implementation while ensuring compliance with GMP, validation, and data integrity requirements.