GMP Automation Program Lead

Pinnaql, Inc.; Rockville (MD); On-site; USD 120,000 - 170,000; Full time

Job summary

Validation & Engineering Group, Inc. in Rockville, MD is seeking an experienced Automation Project Manager to lead automation capital projects in a GMP-regulated manufacturing environment.

You will coordinate engineering, vendors, and cross-functional teams to deliver on time, within budget, and in compliance with regulatory requirements. The role requires a strong engineering or automation background, 8+ years of project management experience, and a proven track record in pharmaceutical/biotech

Qualifications

• Bachelor's degree in Engineering, Automation, Electrical Engineering, Instrumentation, or related technical discipline.

Responsibilities

• Lead automation-related capital projects through planning, design, procurement, implementation, commissioning, and closeout.
• Manage project scope, schedules, budgets, resources, risks, and deliverables to ensure successful execution.
• Coordinate engineering teams, system integrators, contractors, and vendors responsible for automation system upgrades, modifications, and migrations.
• Oversee projects involving building management systems (BMS), environmental monitoring systems (EMS), PLCs, historians, and process automation systems.
• Facilitate cross-functional collaboration to align project activities with manufacturing operations, business priorities, and site requirements.
• Coordinate installation, system integration, testing, commissioning, validation activities with appropriate technical teams.
• Manage project dependencies, change controls, shutdowns, and planned outages to minimize disruption to ongoing manufacturing operations.
• Monitor project progress, resolve execution challenges, and proactively communicate risks, issues, and status updates to stakeholders.
• Ensure project activities and deliverables comply with GMP, safety, quality, and applicable regulatory requirements.
• Oversee project documentation, including engineering deliverables, testing records, and final turnover packages.

Skills

Engineering background

Project management

Cross-functional leadership

Industrial automation

GMP experience

Education

Bachelor's degree in Engineering

Tools

Siemens Desigo/BMS

COPA-DATA Zenon

Rockwell PLCs

Environmental monitoring systems

Job description

Validation & Engineering Group, Inc. in Rockville, MD is seeking an experienced Automation Project Manager to lead automation capital projects in a GMP-regulated manufacturing environment.

You will coordinate engineering, vendors, and cross-functional teams to deliver on time, within budget, and in compliance with regulatory requirements. The role requires a strong engineering or automation background, 8+ years of project management experience, and a proven track record in pharmaceutical/biotech