Automation Engineer

Quality Agents; Rockville (MD); On-site; USD 90,000 - 130,000; Full time

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.

Skills

PLCs

SCADA

DCS

GMP compliance

Validation docs

IQ/OQ/PQ

Process automation

Education

B.S. in STEM

Tools

Allen-Bradley

Siemens

DeltaV

Rockwell

Wonderware/AVEVA

Job description

Quality Agents, LLC offers validation and quality expertise to the pharmaceutical and biotechnology industries. We are seeking a hands-on and detail-driven Automation Engineer to support the design, implementation, and maintenance of automation systems in a regulated biotech manufacturing environment. This role will play a key part in optimizing equipment performance, ensuring data integrity, and maintaining GMP compliance across automated systems. The ideal candidate has experience with PLCs, SCADA, building management systems (BMS), and process automation in GMP settings.

Key Responsibilities

• Support automation projects related to manufacturing, utilities, and lab systems (e.g., bioreactors, chromatography skids, CIP/SIP systems).
• Develop, modify, and troubleshoot automation logic (PLC, SCADA, DCS) in support of process control and equipment integration.
• Work closely with cross-functional teams on system requirements, design specifications, and commissioning/qualification (IQ/OQ/PQ) activities.
• Maintain and update automation-related documentation including functional specs, FRS, URS, and validation protocols.
• Ensure compliance with 21 CFR Part 11, data integrity, GAMP5, and other relevant GMP regulations.
• Collaborate with QA, Validation, Engineering, and IT to support system lifecycle management and change control.
• Support deviation investigations, CAPAs, and root cause analysis for automation-related issues

Minimum Requirements

• B.S. in Electrical Engineering, Chemical Engineering, Computer Science, or a related field.
• 3+ years of experience in automation engineering within a biotech, pharmaceutical, or GMP-regulated environment.
• Experience with automation platforms such as Allen-Bradley, Siemens, DeltaV, Rockwell, Wonderware/AVEVA, or similar.
• Strong understanding of control systems, instrumentation, and network infrastructure in GMP settings.
• Familiarity with automation validation and documentation standards.

Quality Agents offers a full suite of benefits for full-time employees including:

• Health, dental and vision insurance
• Life, AD&D and Disability Insurance
• Health savings account for participants in our health plan
• 401k retirement plan
• Paid time off
• Paid holidays