Key Roles & Responsibilities

Calibration Management

- Perform calibration of instruments as per approved calibration schedules.
- Ensure all critical and non-critical instruments are calibrated within due dates.
- Maintain traceability of calibration standards to national/international standards.
- Review calibration results and determine instrument suitability for use.
- Ensure calibration status labeling of instruments across the site.
- Coordinate calibration activities with production and support departments.

Instrument Maintenance & Troubleshooting

- Perform preventive maintenance of process and utility instruments.
- Troubleshoot instrument failures and measurement deviations.
- Repair or coordinate replacement of faulty instruments.
- Support maintenance activities for field instruments and control systems.
- Minimize downtime caused by instrument-related issues.
- Ensure availability of critical instrument spares.

Manufacturing Equipment Support

- Support calibration of instruments associated with manufacturing equipment.
- Calibrate temperature, pressure, flow, vacuum, level, and RPM measuring devices.
- Ensure production equipment instruments remain within acceptable tolerance limits.
- Assist during equipment qualification and commissioning activities.
- Maintain calibration records for all production equipment instruments.

Utility System Instrumentation Support

- Calibrate instruments associated with HVAC, Water Systems, Boilers, Chillers, Air Compressors, and Building Management Systems.
- Support calibration activities for PW, WFI, Pure Steam, and clean utility systems.
- Monitor utility instrument performance and reliability.
- Ensure accuracy of utility monitoring systems.

Laboratory Instrument Support

- Coordinate calibration of laboratory instruments and measuring devices.
- Ensure compliance of QC instruments with calibration requirements.
- Maintain records of external calibration certificates.




- Review calibration reports and identify deviations or out-of-tolerance conditions.

Compliance & Documentation

- Maintain calibration master list and calibration schedule.
- Update calibration records in computerized maintenance systems (CMMS).
- Ensure compliance with cGMP, GDP, Data Integrity, and regulatory requirements.
- Prepare and revise SOPs related to calibration and instrumentation.
- Maintain calibration certificates, reports, and audit-ready documentation.
- Support internal audits, customer audits, and regulatory inspections.

Deviation, Investigation & CAPA

- Participate in investigations involving calibration failures and instrument deviations.
- Assess impact of out-of-tolerance instruments on product quality and operations.
- Support root cause analysis and CAPA implementation.
- Track closure of calibration-related deviations and observations.
- Ensure timely execution of corrective actions.

Qualification & Validation Support

- Support IQ, OQ, PQ activities of manufacturing equipment and utilities.
- Participate in validation studies requiring calibrated instruments.
- Verify calibration status during qualification activities.
- Support periodic review and requalification programs.

Vendor & Contractor Coordination

- Coordinate with external calibration agencies and service providers.
- Verify competency and qualification status of calibration vendors.
- Review and approve vendor calibration certificates.
- Ensure contracted calibration activities are completed as scheduled.
- Monitor vendor compliance with site requirements.

Safety, Health & Environment





- Follow site safety procedures during calibration and maintenance activities.
- Adhere to lockout-tagout (LOTO) and permit-to-work requirements.
- Participate in safety observations and risk assessments.
- Ensure secure handling and storage of calibration standards.
- Support implementation of EHS initiatives.

Continuous Improvement

- Improve calibration compliance and instrument reliability.
- Participate in Lean, TPM, and Operational Excellence initiatives.
- Implement automation and digitalization projects related to calibration management.
- Optimize calibration frequencies based on risk and historical performance data.
- Drive improvements in calibration turnaround time.

Cross-Functional Coordination

- Coordinate with Production, QA, QC, Validation, Engineering, Projects, and EHS teams.
- Support audits, inspections, shutdowns, and qualification activities.
- Participate in engineering review meetings and reliability improvement initiatives.
- Provide technical expertise on instrumentation and measurement systems.

Qualifications

Educational Qualification

- B.Tech / B.E. in Instrumentation Engineering, Electronics & Instrumentation Engineering, Electrical & Electronics Engineering, Electronics Engineering, or related discipline.
- Diploma in Instrumentation/Electronics with relevant pharmaceutical experience may also be considered.

Experience

- 6-10 years of experience in calibration, instrumentation, or engineering functions within pharmaceutical, biotechnology, API, vaccine, or regulated manufacturing industries.
- Experience in GMP-regulated environments and computerized calibration systems preferred.

Skills: water systems , Troubleshooting, Tpm, Preventive Maintenance, Lean, Operational Excellence, Boilers, Cgmp, Air Compressors, Chillers, Building Management Systems, data integrity, Automation

Experience: 6.00-12.00 Years

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