Walk-in Drive - Instrumentation Engineer - Injectables & OSD

4 - 6 years

5 - 6 Lacs

Posted:7 hours ago| Platform: Naukri logo

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Skills Required

compliance & regulatory support instrumentation operation & maintenance plc/scada/dcs systems troubleshooting calibration & documentation

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

Key Responsibilities

1. Instrumentation Operation & Maintenance

  • Perform routine, preventive, and breakdown maintenance of all instrumentation equipment in Injectable & OSD production areas.
  • Troubleshoot PLC-, SCADA-, and DCS-based systems to ensure operational reliability.
  • Maintain instruments such as pressure/temperature transmitters, flowmeters, control valves, RH/temperature sensors, VFDs, weighing systems, CIP/SIP instrumentation, and autoclave controllers.

2. Calibration & Documentation

  • Execute scheduled calibrations for critical instruments as per USFDA, cGMP, and internal SOP requirements.
  • Maintain calibration records in compliance with ALCOA+ principles.
  • Ensure calibration master lists, traceability certificates, and calibration SOPs are always up-to-date.

3. Compliance & Regulatory Support

  • Support USFDA, EMA, WHO, and other regulatory inspections with complete instrumentation documentation and readiness.
  • Ensure compliance with cGMP, 21 CFR Part 11, and data integrity guidelines.
  • Participate in qualification and validation activities (URS, DQ, IQ, OQ, PQ) for new equipment.

4. Project & Equipment Management

  • Assist in instrumentation installation for new projects or equipment upgrades.
  • Coordinate with vendors/contractors for servicing and technical support.
  • Evaluate new instrumentation technologies to improve manufacturing efficiency and compliance.

5. Cross-Functional Coordination

  • Work closely with Production, QA, QC, EHS, and Validation teams to ensure uninterrupted operations.
  • Support deviation investigations, CAPA implementation, and change control procedures related to instrumentation.

Required Skills & Competencies

  • Strong understanding of instrumentation principles in pharmaceutical manufacturing.
  • Hands-on experience with PLC/SCADA/DCS systems.
  • Knowledge of cGMP, USFDA guidelines, and 21 CFR Part 11 compliance.
  • Ability to interpret P&IDs, wiring diagrams, loop diagrams, and technical manuals.
  • Strong analytical, troubleshooting, and documentation skills.
  • Good communication and team collaboration.

Qualifications & Experience

  • Diploma / B.Tech / B.E. (Instrumentation, Electronics, or Electrical).
  • 26 years’ experience in Instrumentation within Injectable and/or OSD manufacturing.
  • Experience in veterinary or human pharmaceutical USFDA-approved plants preferred.

Additional Desirable Knowledge

  • Exposure to Clean Room instrumentation.
  • Understanding of HVAC, Utility instrumentation, and BMS/EMS systems.
  • Knowledge of EHS requirements relevant to pharma manufacturing.

Preferred candidate profile

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Cronus Pharma

Biopharmaceuticals

San Diego

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