About this role
Job title: Instrumentation & Automation Engineer
About the Role Instrumentation & Automation Engineer responsible for calibration, validation, and maintenance of instrumentation and automation systems across manufacturing operations. You will ensure GDP and cGMP adherence, and 21 CFR Part 11 compliance for computerized systems, driving CAPA-based improvements.
What You'll Do
- Coordinate with the production team and perform/review instrument calibration and all related certificates as per SOP.
- Implement GDP per the Company’s Quality policy for ESD.
- Prepare and update calibration master list and calibration schedules.
- Prepare Calibration and Automation SOPs.
- Execute calibration activities as per approved schedules and ensure all instruments are calibrated and closed in SAP.
- Investigate automation & calibration failures and determine root-cause with appropriate CAPA.
- Ensure preventive maintenance of Distributed Control System (DCS), PLC, HMI, Data Logger system, production area and ZLD area.
- Perform breakdown, preventive and proactive maintenance of all instruments and control systems.
- Ensure drawings and technical specifications of Automation and Instrumentation systems at site are up to date.
- Ensure 21 CFR Part 11 compliance for Computerized System Validation.
- Oversee periodic review and Backup/Restore for Computerised System.
- Prepare IQ and OQ addendum qualification for Computerised System.
- Ensure cGMP implementation in your area as per the QMS.
- Maintain good housekeeping and SHE targets per site objectives.
- Support in manufacturing of chemically synthesized Food Ingredients.
- Prepare, review and execute validation/qualification documents as required.
What We're Looking For
- B.Tech (Instrumentation) with 5-7 years of experience.
- Experience with calibration, automation, GDP, 21 CFR Part 11, CSV, IQ/OQ/PQ, SAP, PLC/DCS/HMI/Data Logger.
- Knowledge of QMS, cGMP, CAPA, root cause analysis, and GMP documentation.
- Strong documentation, problem-solving, and collaboration skills.
Compensation & Benefits
- Benefits offered include joining & relocation support, family support (maternity & paternity benefits), learning and development opportunities, medical coverage for yourself and your family, and life coverage for yourself. You are trained on data up to October 2023.