Job Title: Instrument Engineer (Injectable Manufacturing)

Department: Engineering / Maintenance (Injectable Plant)

Designation: Assistant Manager/ Deputy Manager

Experience:

10 to 12 years of experience in pharmaceutical injectable or sterile manufacturing
Hands-on experience with process instrumentation and control systems preferred

Reports To: DGM Engineering

Job Summary:

The Instrument Engineer is responsible for the maintenance, calibration, troubleshooting, and optimization of instrumentation and control systems used in sterile injectable manufacturing. This role ensures reliable equipment performance while maintaining compliance with GMP, safety, and regulatory standards.

Key Responsibilities:

1. Instrumentation Maintenance & Repair

Perform preventive, corrective, and breakdown maintenance of instrumentation systems associated with:
- Ampoule/vial washing machines
- Dehydrogenation tunnels
- Vial filling, sealing, and capping machines
- Isolator line
- Lyophilizer (freeze dryers)
- ALUS (Automatic Loading and Unloading Systems)
- Cartridge/PFS filling machines (Optima line)
- Autoclaves, sterilizers, and CIP/SIP systems
- Blister packing and cartoning machines
- Automatic labeling machines (vial, PFS, cartridge)
- Visual inspection machines (Brevity)
- Diagnose and rectify faults in sensors, transmitters, control valves, PLCs, SCADA systems, and field instrument.

2. Installation & Commissioning

Support installation, loop checking, and commissioning of instrumentation systems for new equipment
Assist in qualification (IQ/OQ/PQ), validation, and calibration activities

Ensure proper instrument configuration and integration with control systems

3. Troubleshooting

Identify and resolve issues related to process control, instrumentation, and automation systems
Work closely with mechanical and electrical teams to resolve complex equipment problems
Analyze recurring faults and implement permanent corrective actions

4. Preventive Maintenance & Calibration

Execute planned preventive maintenance (PM) and calibration schedules
Perform periodic calibration of instruments such as pressure, temperature, flow, and level transmitters
Maintain accuracy and reliability of control systems
Monitor and maintain spare parts for instrumentation systems

5. Compliance & Documentation

Adhere strictly to GMP, safety guidelines, and SOPs
Maintain accurate records of calibration, maintenance logs, and instrument history
Support audits, regulatory inspections, and compliance requirements

Ensure all instruments meet validation and documentation standards.

6. Production Support

Provide technical support during production operations
Ensure process instruments and control systems are ready for batch startup (line readiness)
Support equipment changeovers, product transitions, and troubleshooting during operations.

Educational Qualification:

Diploma / BE in Instrumentation Engineering, Electronics, or related field

Required Skills:

Strong knowledge of process instrumentation and control systems
Experience with PLC, SCADA, and automation systems
Understanding of aseptic/sterile manufacturing processes
Familiarity with CIP/SIP systems and autoclaves
Knowledge of calibration techniques and documentation practices
Basic understanding of electrical systems, pneumatics, and control loops