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.
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.
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.
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.
