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.