Instrumentation Engineer

05 – 11 years of hands‑on experience in Engineering (Instrumentation) within OSD / Sterile / Injectable / or Aseptic Pharmaceutical Manufacturing environments. Education : B.E. / B.Tech in Instrumentation, Electronics, or related Engineering disciplines , with relevant functional pharmaceutical industry experience. Key Responsibilities : Carry out installation, calibration, preventive maintenance, and troubleshooting of instrumentation systems, including but not limited to: Autoclaves, Isolators, RABS, and Grade A/B cleanroom monitoring systems, Pressure differential, temperature, humidity (RH), flow, and level instruments, WFI, pure steam, and clean compressed air systems.

Ensure timely calibration of critical instruments in line with GMP requirements , and maintain calibration records traceable to national and international standards . Hands‑on experience in Computer System Validation (CSV) and equipment and utility qualification and validation activities activities, including URS, DQ, IQ, OQ, and PQ , in line with GAMP guidelines and cGMP requirements Collaborate with Quality, Manufacturing, IT and CFT teams to ensure compliance as per the Global regulatory standards (USFDA, MHRA, EU‑GMP, WHO, etc.). Maintain comprehensive instrumentation documentation , including SOPs, calibration certificates, equipment history cards, deviations, and change control records.

Implement, operate, and monitor EMS and BMS Provide technical inputs for deviations, CAPAs, risk assessments , and root‑cause investigations related to instrumentation systems. Ensure strict adherence to data integrity requirements (21 CFR Part 11) for instruments with electronic or data‑logging systems. Assist in the selection, specification, and procurement of instrumentation for new projects, expansions, and system upgrades.

Perform troubleshooting of control system–related hardware and software issues to ensure system reliability and uptime, analysis of control system operational issues Proficient in system backup and restoration , data logging, historian management, AMS , and ensuring compliance with 21 CFR Part 11 and QMS standards. Required Skills & Knowledge : Strong understanding of global pharmaceutical regulatory requirements and compliance standards. Hands‑on experience with BMS, EMS, SCADA, and PLC‑based systems in sterile manufacturing environments.

Demonstrated excellent documentation skills , with strong attention to detail and a compliance‑driven approach. Effective communication skills with the ability to collaborate across cross‑functional teams.