Senior Automation Engineer - GMP Validation & Controls

Pinnaql, Inc.; 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 support an Automation Resilience Program.

You will provide automation engineering support for design, integration, testing, commissioning, validation, and troubleshooting of manufacturing systems in a regulated environment. The role requires close collaboration with the Automation Project Manager, Engineering, Operations, Quality, Validation, IT, and external vendors, ensuring GMP compliance, data

Qualifications

• 8+ years of experience in automation, controls, engineering, or related manufacturing environments.
• Experience in GMP-regulated environments.
• Hands-on experience with automation design, configuration, integration, testing, or troubleshooting.
• Experience with commissioning, testing, qualification, or validation activities.
• Ability to work on site in Rockville, MD and collaborate with site teams.

Responsibilities

• Provide automation engineering support from design and planning through implementation, testing, commissioning, and closeout.
• Support modifications and improvements to BMS, COPA-DATA Zenon, EMS, PLCs, and process automation systems.
• Support engineering design, system integration, migration, controls modifications, and implementation activities.
• Perform and support automation system configuration, programming, testing, troubleshooting, and technical issue resolution.
• Support testing, commissioning, and validation activities.
• Support creation, execution, review, and approval of validation protocols in accordance with site requirements.
• Provide technical support during system outages, shutdowns, migrations, and implementation activities in an active manufacturing environment.
• Ensure automation activities comply with GMP, safety, quality, data integrity, and site procedures.
• Review and maintain engineering drawings, configuration records, control documentation, test documentation, and as-built/turnover packages.
• Work with internal stakeholders, vendors, system integrators, and subcontractors throughout project execution.
• Identify and communicate technical risks, issues, dependencies, and potential impacts to safety, compliance, schedule, quality, or operations.
• Support troubleshooting and resolution of automation, controls, communications, and system integration issues.

Skills

Technical problem-solving

Communication

Documentation

Cross-functional collaboration

Education

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

Tools

Siemens Desigo / BMS

COPA-DATA Zenon

Rockwell PLC / Controls

Environmental Monitoring Systems (EMS)

Job description

Validation & Engineering Group, Inc. in Rockville, MD is seeking a Senior Automation Engineer to support an Automation Resilience Program.

You will provide automation engineering support for design, integration, testing, commissioning, validation, and troubleshooting of manufacturing systems in a regulated environment. The role requires close collaboration with the Automation Project Manager, Engineering, Operations, Quality, Validation, IT, and external vendors, ensuring GMP compliance, data