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Introduction:

Automation Engineer

Responsibilities:

1. Design, develop, and maintain automation systems including PLC, HMI, SCADA, and robotic applications to support extrusion and post-processing lines.
2. Monitor and improve existing automation equipment to increase production efficiency and reduce downtime.
3. Collaborate with cross-functional teams (Production, Quality, and Maintenance) to troubleshoot issues and implement root cause solutions.
4. Ensure all automation and control systems comply with medical device standards such as ISO 13485, 21 CFR Part 11, and GMP requirements.
5. Maintain cleanroom-compatible equipment and ensure system integration does not compromise Class 100,000 (ISO Class 8) cleanroom integrity.
6. Support qualification and validation of automation systems (IQ, OQ, PQ) for regulatory compliance.
7. Create and maintain technical documentation such as electrical drawings, logic flowcharts, and system manuals.
8. Provide training and technical support to production and maintenance staff.
9. Lead or support continuous improvement and lean initiatives related to automation.

Requirements:

1. Bachelors degree in Automation Engineering, Electrical Engineering, Mechatronics, or a related field.
2. Minimum 3 years of experience in automation within a manufacturing environment, preferably in medical device or plastic extrusion industries.
3. Proficient in PLC programming (Siemens, Allen Bradley, Omron, etc.), HMI development, and industrial networking.
4. Familiar with standards and regulatory requirements such as ISO 13485, GMP, and cleanroom protocols.
5. Experience in process validation (IQ/OQ/PQ) and documentation for regulated industries.
6. Strong problem-solving skills with a hands-on approach.
7. Able to communicate effectively in English, both written and spoken.
8. Team-oriented, detail-focused, and able to work under tight timelines.