Automation Engineer (NPI Projects)
Summary:
Provides technical leadership and project management for automation and control system activities supporting manufacturing and new product introductions (NPI). Ensures reliable, compliant, and optimized automation systems aligned with GMP and business goals.
Responsibilities
1. Provide technical support for all control system issues, including troubleshooting, optimization, and documentation.
2. Lead control system qualification, commissioning, and lifecycle management to GAMP-5 standards.
3. Manage automation aspects of NPI, capital, and continuous improvement projects.
4. Develop integration plans for MES, ERP, and plant historian systems.
5. Ensure compliance with EHS, GMP, and regulatory standards; report incidents and support EHS initiatives.
6. Propose long-term automation system maintenance and improvement strategies.
7. Collaborate cross-functionally with engineering, maintenance, IT, and production teams.
8. Mentor junior engineers and provide automation training where required.
Requirements
9. Bachelor's or higher degree in Engineering, Mechatronics, IT, or a related discipline (Master's desirable).
10. 3+ years' experience in process automation within a GMP pharmaceutical environment.
11. Expertise in PLC, SCADA/HMI systems (e.g., Siemens, Rockwell) and industrial networks (Profinet, Profibus, Modbus, CANBus).
12. Strong understanding of 21 CFR Part 11, EU Annex 11, and GAMP-5 compliance.
13. Experience integrating automation systems with MES/ERP and plant historians (OSI-PI, Ignition, OPC).
14. Proficiency in Windows OS administration, network architecture, and system change management.
15. Strong analytical, communication, and leadership skills with a focus on quality and safety.
16. Self-motivated, detail-oriented, and capable of working autonomously on complex projects.
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