Senior Automation Engineer — GMP Validation & Project Lead

Pinnaql; Rockville (MD); On-site; USD 110,000 - 160,000; Full time

Job summary

Validation & Engineering Group, Inc. in Rockville, MD is seeking a Senior Automation Engineer to lead automation projects in a GMP environment.

You will coordinate design, testing, validation, and implementation with cross-functional teams including Engineering, Operations, Quality, Validation and IT. The role requires 8+ years of experience in automation/controls, strong project execution skills, and experience with commissioning, testing and validation activities.

Qualifications

• Bachelor's degree in engineering or related field.
• 8+ years of experience in automation, controls or related manufacturing environments.
• Experience in GMP-regulated environments such as pharma/biotech/medical devices.
• Strong project execution and stakeholder management skills.
• Experience with commissioning, testing, qualification or validation activities.

Responsibilities

• Lead automation projects from design and planning through implementation and closeout.
• Support modifications to BMS, COPA-DATA Zenon, EMS, PLCs and process automation systems.
• Coordinate engineering design, system integration, migration and validation activities.
• Develop and coordinate testing, commissioning and validation activities.
• Review and approve validation protocols per site requirements.
• Manage project schedules, risks, changes, and work orders.
• Coordinate outages and implementations in active manufacturing environments.
• Ensure GMP, safety, quality, and site procedures compliance.
• Maintain engineering drawings, config records and turnover packages.
• Coordinate with vendors and subcontractors for project delivery.
• Escalate risks impacting safety, compliance, schedule, quality, or operations.

Skills

Automation

Controls

Project management

GMP

Education

Bachelor's degree in Engineering/Automation/Controls/Instrumentation or related field

Tools

Rockwell PLC

SCADA

Job description

Validation & Engineering Group, Inc. in Rockville, MD is seeking a Senior Automation Engineer to lead automation projects in a GMP environment.

You will coordinate design, testing, validation, and implementation with cross-functional teams including Engineering, Operations, Quality, Validation and IT. The role requires 8+ years of experience in automation/controls, strong project execution skills, and experience with commissioning, testing and validation activities.