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 secure 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

- 3-7 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) capability7

Skills: Hmi, Kaizen, Tpm, Calibration, Preventive Maintenance, Lean, Predictive Maintenance, Plc, Scada

Experience: 0.00-0.00 Years

📌 Team Member - Engineering (Instrumentation ) (India)
🏢 Monster - xshruthix
📍 India