Controls & Automation Engineer - GMP Manufacturing

Position Summary:

Seeking a mid-level Automation Engineer to support the design, integration, commissioning, qualification, validation, and operation of automated warehouse and packaging systems in a GMP-regulated environment. The role focuses on packaging line automation, robotics, controls, and system integration while ensuring compliance with cGMP, FDA, and 21 CFR Part 11 requirements.

Key Responsibilities:

• Support design, integration, and startup of automated warehouse and packaging systems.
• Lead commissioning, qualification, validation (CQV), and operational readiness activities.
• Develop and maintain automation, controls, and compliance documentation.
• Ensure systems meet GxP, FDA, safety, and data integrity requirements.
• Collaborate with Packaging, Warehouse, Quality, CSV, IT/OT, and external vendors.
• Support PLC, HMI, and SCADA systems (Allen-Bradley, Siemens, PanelView, RSView).
• Drive automation reliability, system improvements, and Industry 4.0 initiatives.
• Coordinate with vendors and system integrators to deliver project objectives.

Required Qualifications:

• Bachelor’s or Master’s degree in Engineering (Automation, Electrical, Mechanical, or related field).
• Experience in GMP-regulated manufacturing environments.
• Hands-on experience with industrial automation, controls, and system integration.
• Experience with robotics, automated material handling systems, and packaging automation preferred.
• Knowledge of CSV, 21 CFR Part 11, data integrity, OT/IT integration, and industrial networking.
• Familiarity with Industry 4.0 and IIoT technologies.
• Strong communication and cross-functional collaboration skills.
• Ability to travel occasionally as required.

Preferred Skills:

PLC/HMI/SCADA systems, CQV, CSV, GMP compliance, robotics, warehouse automation, packaging line integration, industrial networking, OT/IT integration, Industry 4.0, and IIoT technologies.