Senior Officer - Instrumentation Engineer

Position: Instrumentation Engineer

Experience: 35 Years

Location: Goa

Employment Type: Full-Time

Job Summary

We are looking for a skilled Instrumentation Engineer with 35 years of experience in Industrial Automation, Instrumentation, Computerized System Validation (CSV), and Level-2 (L2) System Integration. The role involves execution of 21 CFR Part 11 compliance and upgrade projects, including system assessment, implementation, validation, troubleshooting, and integration with manufacturing systems. The candidate will work closely with cross-functional teams including Engineering, Production, QA, Validation, IT, MES, Vendors, and System Integrators.

Key Responsibilities

1. Execute and support 21 CFR Part 11 compliance and remediation projects for PLC, HMI, SCADA, DCS, and computerized systems.

2. Perform system assessments, site surveys, and identify compliance gaps and upgrade requirements.

3. Implement and troubleshoot industrial automation and instrumentation systems.

4. Support L2 integration between PLC, SCADA, DCS, Historian, MES, ERP, and other manufacturing systems.

5. Configure and troubleshoot industrial communication protocols such as OPC UA/DA, Modbus TCP/IP, Profibus, Profinet, Ethernet/IP, and MQTT.

6. Participate in FAT, SAT, commissioning, IQ/OQ/PQ, and CSV activities.

7. Conduct loop checking, I/O testing, panel inspections, and system validation.

8. Prepare and maintain GMP-compliant documentation, validation records, SOPs, and change controls.

9. Collaborate with Vendors, Users, QA, Validation, Engineering, IT, and MES teams to ensure successful project execution.

10. Ensure compliance with GMP, GAMP5, Annex 11, 21 CFR Part 11, and Data Integrity requirements.

Required Technical Skills

1. PLC: Siemens, Allen-Bradley, Schneider, Mitsubishi

2. HMI/SCADA: WinCC, Zenon, Wonderware, iFIX, FactoryTalk, Ignition

3. DCS: DeltaV, Yokogawa, Honeywell, ABB

4. L2 Integration, Historian, MES, and ERP Integration

5. Industrial Protocols: OPC UA/DA, Modbus, Ethernet/IP, Profibus, Profinet, MQTT

6. Instrumentation: Sensors, Transmitters, Control Valves, VFDs, MCC

7. Electrical Systems: Panel Wiring, Single Line Diagrams (SLD), Loop Diagrams, Cable Termination

8. PLC Programming, HMI Development, Alarm Management, Tag Integration

9. Computerized System Validation (CSV), IQ/OQ/PQ, Risk Assessment, Change Control, and GMP Documentation

Desired Skills

1. Strong communication and technical documentation skills

2. Experience in pharmaceutical manufacturing and automation projects

3. Ability to work in cross-functional teams

4. Willingness to travel for project execution and support

Educational Qualification

B.E./B.Tech in Instrumentation, Electrical Engineering, Electronics Instrumentation, or related discipline

Preferred Experience

1. CFR Part 11 Upgrade/Remediation Projects

2. PLC/HMI/SCADA/DCS Commissioning and Validation

3. L2 Integration with MES, ERP, and Historian Systems

4. Computerized System Validation (CSV) in regulated environments . .