Project Engineer (Automation)- Pharma Industry

Position:

Project Engineer (Automation) Location:

Singapore & India (Site-Based – Pharma Projects) Experience : 4–8 Years (Regulated Pharma Mandatory) Industry:

Pharmaceutical.

Role Overview The Pharma Automation Project Engineer will be responsible for complete technical ownership of PLC & DDC -based automation systems within regulated pharmaceutical Environments. The role requires strong expertise in PLC architecture design, validation-compliant programming, system integration, and lifecycle support in GMP-controlled environments. Only candidates with hands-on experience in pharmaceutical automation Project & will be considered. Key Responsibilities * Take end-to-end technical ownership of PLC & DDC -based automation systems implemented in regulated pharmaceutical environments. * Design, develop, and validate PLC & DDC control strategies for pharma process and utility systems including Cleanroom HVAC, Purified Water (PW), Water for Injection (WFI), Clean Steam, CIP/SIP systems, reactors, granulation systems, compression lines, and other critical GMP equipment. * Perform advanced PLC programming using structured and modular approaches in Ladder Logic, Function Block Diagram, and Structured Text, ensuring maintainability and validation traceability. * Develop and validate complex control sequences, interlocks, permissives, batch logic, phase-based control, PID loops, alarm handling logic, redundancy architecture, and fail-safe mechanisms aligned with GMP requirements. * Ensure all PLC systems comply with 21 CFR Part 11, EU Annex 11, and data integrity requirements by implementing secure role-based access control, audit trails, electronic records management, and controlled change management practices. * Lead PLC hardware engineering including CPU selection, I/O configuration, remote I/O systems, network segmentation, redundancy strategies, and industrial communication architecture. * Integrate PLC systems with SCADA/HMI platforms to enable validated real-time monitoring, alarm management, electronic batch records, and historical data logging suitable for regulatory audits. * Interface PLC systems with OEM equipment, analyzers, VFDs, BMS systems, EMS systems, and MES platforms using validated industrial communication protocols such as Modbus, Profibus, BACnet, and Ethernet/IP. * Participate in and lead Computer System Validation (CSV) lifecycle activities including URS review, FDS preparation, Risk Assessment, IQ/OQ protocol execution, traceability matrix management, and deviation handling. * Conduct Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) with full functional verification, interlock validation, alarm challenge testing, and documentation control. * Lead site commissioning activities including I/O verification, loop testing, startup stabilization, troubleshooting in GMP production environments, and post-commissioning performance validation. * Prepare and maintain comprehensive validation documentation including FDS, HDS, SDS, I/O lists, control narratives, cause-and-effect matrices, traceability matrices, and as-built documentation aligned with GAMP 5 guidelines. * Support internal and external regulatory audits (USFDA, MHRA, WHO-GMP) by providing complete automation documentation and technical justifications. * Provide technical leadership in pharma automation design reviews and mentor junior engineers on GMP-compliant programming practices and validation standards.

Required Qualifications

* B.E / B.Tech in Electrical, Instrumentation, Electronics, or related discipline * 4–8 years of hands-on experience in regulated pharmaceutical manufacturing facilities * Demonstrated involvement in at least two complete pharma automation project lifecycles * Advanced PLC programming experience (Siemens / Allen Bradley / Schneider preferred) * Strong understanding of GMP and validation practices. * Experience in 21 CFR Part 11 and Annex 11 compliant system implementation * Exposure to pharma utilities and Process & BMS automation * Experience in validation documentation and audit readiness along with successful commissioning and project handover. Immediate Joiners Preferred.