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
