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).
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.
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.
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.
