Automation Engineer

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 :

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

Quality Agents accepts applications on an on-going basis in order to build a talent pool of potential candidates. These applications remain open for consideration, as positions become available, for one (1) year from the date of application. After that time, or if your application information changes, please submit your application again.