We are looking for a Senior Automation Engineer who will be responsible for the design, installation, commissioning, and maintenance of site-wide control systems. This role ensures that all instrumentation and automation systems (DCS/PLC/SCADA) operate safely, efficiently, and in full compliance with global GMP and 21 CFR Part 11 regulations.
Key Responsibilities
- Lead the maintenance and troubleshooting of Emerson DeltaV DCS, Siemens S7, and Allen Bradley PLC systems.
- Manage the full lifecycle of E&I projects, from URS development and vendor selection to FAT, SAT, and final site handover.
- Execute Computerized System Validation (CSV) activities. Generate and review IQ/OQ/PQ protocols for process equipment and utilities (WFI, HVAC, Clean Steam).
- Review and update P&IDs, Loop Drawings, Instrument Data Sheets, and Cause & Effect matrices.
- Lead investigations into automation-related deviations and implement robust Corrective and Preventive Actions (CAPA).
- Collaborate with Manufacturing, Quality, and HSE teams to minimize downtime and ensure system integrity during live batch production.
Required Qualifications & Skills
- Bachelor's Degree in Instrumentation, Control, or Electrical Engineering. A Master's in Engineering Management is a significant plus.
- Minimum 8-10 years of experience in the GMP industry.
- Hands-on experience with Emerson DeltaV (Batch execution, hardware configuration).
- Proficiency in PLC programming (TIA Portal, RSLogix).
- Experience with high-speed packaging or containment systems (PTS, Isolators).
- Strong understanding of GMP, GAMP 5, and 21 CFR Part 11.
