Automation Engineer, cGMP & Validation (Biotech)

Samsung Biologics; Rockville (MD); On-site; USD 120,000 - 160,000; Full time

Benefits offered by this job

13 paid holidays

Vacation time

401K match

Medical, dental and vision benefits

Job summary

Samsung Biologics is seeking an Automation Engineer to support process control systems, manufacturing equipment, building systems, and plant utilities at the Rockville, MD facility. The role focuses on automation and control system engineering for manufacturing operations, facilities, validation activities, and capital projects while ensuring cGMP and regulatory compliance.

The position demands collaboration with multiple groups and readiness for 24/7 support.

Qualifications

• Bachelor's degree in engineering or a related field.
• Experience supporting cGMP-regulated manufacturing environments.
• Proven ability to support validation activities (IQ/OQ/PQ) and change control.

Responsibilities

• Support and troubleshoot automation and control systems in manufacturing, facilities, labs, and validation.
• Provide engineering support for work requests and project execution to meet requirements and timelines.
• Ensure projects comply with cGMP, SOPs, OSHA, and applicable codes.
• Maintain documentation of all cGMP equipment modifications and upgrades via change control.
• Develop and support validation protocols (IQ/OQ/PQ) and provide technical content.

Skills

Automation engineering

Process control

Troubleshooting

Regulatory compliance

Validation

Education

Bachelor's Degree

Job description

Samsung Biologics is seeking an Automation Engineer to support process control systems, manufacturing equipment, building systems, and plant utilities at the Rockville, MD facility. The role focuses on automation and control system engineering for manufacturing operations, facilities, validation activities, and capital projects while ensuring cGMP and regulatory compliance.

The position demands collaboration with multiple groups and readiness for 24/7 support.