Equipment Engineer- Automation

Equipment Engineer- Automation Equipment

We are seeking an experienced Equipment / Validation Engineer to support highly automated production lines within a regulated medical device manufacturing environment. This role is strongly hands-on, with a focus on troubleshooting automated equipment, leading equipment validation (IQ/OQ/PQ), and supporting the introduction and improvement of complex manufacturing systems.

Key Responsibilities

• Revalidate and support fully automated production lines, ensuring ongoing compliance with regulatory and quality requirements.

• Develop, execute, and maintain equipment validation protocols (IQ/OQ/PQ) and associated documentation.

• Troubleshoot and debug automated production equipment to resolve manufacturing and validation-related issues.

• Support the introduction, transfer, and validation of new equipment, including FATs, SATs, and site handover.

• Work closely with Manufacturing, Quality, Maintenance, and Product Development to meet operational and validation timelines.

• Provide technical input into equipment design, automation upgrades, vision systems, robotics, and new technologies.

• Engage with equipment vendors on technical reviews, FAT execution, and capital project support.

• Drive continuous improvement initiatives to enhance equipment reliability, efficiency, and compliance.

Required Technical Background

• Degree in Engineering or a related technical discipline.

• Proven experience in equipment validation within a medical device or pharmaceutical manufacturing environment.

• Strong hands-on experience troubleshooting automated manufacturing equipment.

• Solid understanding of IQ/OQ/PQ, change control, and regulated documentation practices.

• Familiarity with PLC-controlled equipment (Allen Bradley preferred) and automated systems.

• Experience supporting FAT/SAT and equipment commissioning activities.

• Strong technical documentation and problem-solving skills.

Desirable Experience

• Exposure to vision systems (e.g. Cognex, Keyence) and industrial robotics (e.g. Epson, UR).

• Experience with software validation in regulated environments.

• Working knowledge of FDA and medical device regulatory frameworks.