Automation Engineer – GMP Biotech Systems & Validation

Quality Agents

Rockville (MD)

On-site

USD 90,000 - 130,000

Full time

14 days+

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Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

Life insurance

AD&D insurance

Disability insurance

Health savings account

Job summary

Quality Agents, LLC offers validation and quality expertise to the pharmaceutical and biotechnology industries. We are seeking a hands-on Automation Engineer to design, implement, and maintain automation systems in a regulated biotech manufacturing environment.

This role focuses on optimizing equipment performance, ensuring data integrity, and maintaining GMP compliance across automated systems. The ideal candidate has experience with PLCs, SCADA, BMS, and process automation in GMP settings, and

Qualifications

B.S. in Electrical Engineering, Chemical Engineering, Computer Science, or related field.
3+ years of automation engineering experience in biotech, pharma, or GMP environments.
Experience with automation platforms (AB, Siemens, DeltaV, Rockwell, Wonderware/AVEVA).
Strong understanding of GMP data integrity, documentation, and validation practices.
Familiarity with IQ/OQ/PQ and system lifecycle activities.

Responsibilities

Support manufacturing, utilities, and lab automation projects (bioreactors, CIP/SIP, skids).
Develop, modify, and troubleshoot PLC/SCADA/DCS logic for process control.
Collaborate with cross-functional teams on requirements, design specs, and commissioning/qualification (IQ/OQ/PQ).
Maintain and update functional specs, URS/FRS, and validation protocols.
Ensure compliance with 21 CFR Part 11 and data integrity requirements.
Coordinate with QA, Validation, Engineering, and IT for system lifecycle and changes.
Assist in deviation investigations and CAPAs related to automation.