Team Member Engineering – Instrumentation

Job Purpose To ensure the reliable operation, calibration, troubleshooting, and automation support for all equipment-related instrumentation across the pharma manufacturing site, enabling compliant, safe, and uninterrupted production in line with cGMP, data integrity, and regulatory requirements . Roles & Responsibilities 1. Equipment Instrumentation Management - Manage field instruments used in manufacturing equipment , including: - RMG, FBD, Blenders, Tablet Press, Coaters - Encapsulation & Softgel equipment - Derma mixers, homogenizers, reactors - Packing line instruments (sensors, cameras, checkweighers) - Ensure continuous availability and performance of critical process instruments . - Monitor and maintain transmitters, indicators, load cells, gauges, sensors, and control elements. 2. Automation System Management - Support PLC / SCADA / HMI systems for process equipment. - Execute modifications to logic, alarms, and interlocks under proper change control. - Ensure automation systems comply with 21 CFR Part 11 and data integrity requirements. - Coordinate with automation vendors for advanced troubleshooting and upgrades. 3. Calibration & Compliance - Execute calibration of all equipment instruments as per schedule. - Maintain calibration labels, records, traceability certificates, and calibration history. - Investigate out-of-calibration (OOC) events and support impact assessment. - Ensure compliance with cGMP, ALCOA+, GLP , and site QC/QA expectations. 4. Breakdown, Preventive & Predictive Maintenance - Attend equipment-related instrumentation breakdowns to minimize downtime. - Perform preventive maintenance of instruments and automation panels. - Diagnose and resolve issues like signal failures, drift, noise, and PLC communication faults. - Support predictive maintenance activities using trend data and failure history. 5. Documentation & QMS Requirements - Maintain and update: - Calibration records - Instrument history cards - Maintenance and breakdown logs - Job completion reports - Ensure compliance with SOPs, deviations, CAPA, change control , and internal audit requirements. - Ensure all documentation is accurate, contemporaneous, and audit-ready . 6. Cross-Functional Coordination - Work with Production to ensure equipment readiness and process continuity. - Coordinate with QA for calibration approvals, deviations, and audit responses. - Support QC during instrument-related sampling/testing requirements. - Collaborate with Engineering / Maintenance teams for utilities/equipment support. 7. Safety, EHS & Good Engineering Practices - Follow electrical safety, LOTO, PPE, and MSDS guidelines. - Ensure safe working during instrumentation maintenance in GMP zones. - Maintain 5S and housekeeping in instrument rooms, panels, and shopfloor areas. 8. Audit & Inspection Support - Support internal audits, customer audits, and regulatory inspections . - Provide instrumentation/automation documents and explain system controls. - Ensure timely closure of audit observations related to instrumentation. 9. Continuous Improvement & Digitalization - Drive improvements to enhance instrument reliability, MTBF, and reduce failures . - Implement Lean, Kaizen, TPM initiatives for equipment instrumentation. - Support digital data collection, dashboards, and automation enhancements. Educational Qualification - Diploma / B.E. / B.Tech in: - Instrumentation Engineering - Electronics & Instrumentation - Electronics Engineering - Electrical Engineering (with instrumentation exposure) - Certification in PLC / SCADA / Automation is an added advantage. Experience - 6-12 years of experience in equipment instrumentation and automation in a pharma manufacturing site . - Hands-on work with field instruments, PLC/SCADA systems, and GMP documentation . - Experience in regulated environments (US-FDA, EU-GMP, WHO-GMP) preferred. Key Skills & Competencies - Strong knowledge of equipment instrumentation - PLC/SCADA troubleshooting skills - Calibration, maintenance & validation exposure - Understanding of cGMP, data integrity & pharma processes - Good documentation discipline - Problem-solving & RCA (Root Cause Analysis) capability Skills: Hmi, Kaizen, Tpm, Calibration, Preventive Maintenance, Lean, Predictive Maintenance, Plc, Scada Experience: 6.00-12.00 Years