OEE Implementation Lead for Pharma (GxP, MES)

TechDigital Group; North Carolina; Híbrido; USD 120.000 - 180.000; Jornada completa

Descripción de la vacante

TechDigital Group is seeking an experienced Project Manager to lead the OEE implementation in a GMP/GxP environment for pharmaceutical/biotech operations in the United States. The role requires coordinating cross-functional teams, managing vendors, and ensuring quality, security, and governance across the project lifecycle.

The ideal candidate has extensive PM experience, hands-on OEE deployment expertise, and a proven ability to deliver projects within regulated manufacturing settings.

Formación

• 8–11 years of overall Project Management experience with full lifecycle ownership.
• 5+ years of experience in the pharmaceutical/biotech industry.
• Experience delivering projects in a GxP-regulated environment.

Responsabilidades

• Lead end-to-end project management of the OEE implementation, from planning through deployment and stabilization.
• Develop and maintain project plans, schedules, budgets, and resource allocation across the project lifecycle.
• Coordinate cross-functional teams including business stakeholders, technical/solution architects, vendors, and operations.
• Manage vendor relationships and deliverables related to OEE solution design, configuration, and deployment.
• Track project risks, issues, dependencies, and mitigation plans, escalating proactively as needed.
• Ensure project delivery adheres to GxP compliance, data governance, and IT security requirements.
• Drive project governance including status reporting, steering committee updates, and stakeholder communication.
• Manage scope, change control, and integration points with MES, IoT devices, data historians, and enterprise systems.
• Support change management and end-user readiness activities for OEE rollout.
• Ensure project documentation (charters, plans, status reports, lessons learned) is complete and audit-ready.

Conocimientos

OEE project management

GxP environment

Pharma/biotech PM experience

Educación

PMP certification or equivalent

Descripción del empleo

TechDigital Group is seeking an experienced Project Manager to lead the OEE implementation in a GMP/GxP environment for pharmaceutical/biotech operations in the United States. The role requires coordinating cross-functional teams, managing vendors, and ensuring quality, security, and governance across the project lifecycle.

The ideal candidate has extensive PM experience, hands-on OEE deployment expertise, and a proven ability to deliver projects within regulated manufacturing settings.