Senior Calibration Engineer

Job Purpose

The Senior Calibration Engineer will be responsible for planning, executing, reviewing, and managing calibration activities for critical measuring and monitoring instruments used in pharmaceutical, healthcare, cosmetics, food, and other regulated industries.

The position requires strong technical knowledge of calibration principles, metrology, GMP requirements, validation practices, documentation, and applicable international standards. The engineer will also be responsible for leading calibration activities at client sites and ensuring that all calibration work is completed accurately, safely, and in accordance with approved procedures and regulatory requirements.

Key Responsibilities

A. Calibration Activities

• Plan and execute calibration of process, utility, HVAC, laboratory, and production instruments.
• Perform calibration of instruments including:
• Temperature sensors, RTD, thermocouples and transmitters
• Pressure and differential pressure gauges/transmitters
• Humidity and RH sensors
• Temperature/RH data loggers
• Flow meters and transmitters
• Level instruments
• Weighing balances and weighing systems
• pH meters and conductivity meters
• RPM/tachometers
• Timers and counters
• Vacuum gauges
• Gas pressure instruments
• Electrical measuring instruments
• Other critical measuring and monitoring devices.
• Perform calibration using appropriate reference standards and calibration equipment.
• Conduct calibration as per approved SOPs, test procedures, calibration methods and client requirements.
• Evaluate calibration results against defined acceptance criteria and tolerances.
• Identify out-of-tolerance (OOT) conditions and initiate appropriate investigation and reporting.

B. GMP / Validation Responsibilities

• Ensure calibration activities comply with applicable GMP and regulatory requirements.
• Understand and apply requirements of:
• EU GMP
• WHO GMP
• US FDA requirements
• PIC/S GMP
• ISO 17025
• ISO 9001
• ISO 14644 where applicable
• GAMP 5 principles where applicable.
• Support qualification and validation activities related to instrumentation and measuring systems.
• Participate in IQ/OQ/PQ activities where calibration expertise is required.
• Review calibration requirements identified in URS, DQ, IQ, OQ and PQ documentation.
• Support risk assessment for critical instruments and measuring systems.

C. Documentation

• Prepare and review calibration certificates and reports.
• Maintain calibration records, instrument history cards and calibration databases.
• Review calibration raw data and calculations.
• Ensure proper traceability of reference standards.
• Maintain calibration status labels and records.
• Prepare deviation, OOT and investigation reports when required.
• Review calibration SOPs, test protocols, formats and work instructions.
• Ensure ALCOA+ principles are followed for GMP documentation.

D. Reference Standards & Equipment

• Maintain and control calibration standards and reference instruments.
• Ensure reference standards have valid calibration certificates and appropriate traceability.
• Verify uncertainty, accuracy, resolution and range of reference standards before use.
• Support preparation and maintenance of the laboratory's master equipment list.
• Assist in determining calibration intervals based on risk, historical data and equipment criticality.
• Coordinate external calibration of reference standards through accredited laboratories where required.

E. Client & Site Responsibilities

• Lead calibration teams at pharmaceutical and regulated manufacturing sites.
• Coordinate daily activities with client engineering, QA, production and validation teams.
• Understand client specifications and site-specific calibration procedures.
• Attend technical meetings and provide technical clarification to clients.
• Ensure calibration activities are completed within agreed schedules.
• Identify technical issues at site and propose appropriate solutions.

F. Team Leadership

• Lead and supervise calibration engineers and technicians.
• Allocate daily calibration activities and monitor execution.
• Train junior engineers and technicians on calibration techniques and GMP documentation.
• Review technical work performed by team members.
• Ensure compliance with safety procedures and site requirements.
• Support technical evaluation and training of new employees.

Technical Competencies

The candidate should have strong knowledge of:

• Calibration principles and metrology.
• Measurement uncertainty.
• Accuracy, precision, repeatability and reproducibility.
• Tolerance and acceptance criteria.
• Traceability of measurement standards.
• Calibration interval determination.
• OOT investigation.
• Instrument identification and criticality assessment.
• GMP documentation practices.
• Qualification and validation principles.
• ISO/IEC 17025 requirements.
• Basic statistical evaluation of calibration data.
• Electronic calibration management systems.

Knowledge of computerized calibration management systems (CMMS/CAFM/Calibration Management Software) will be an advantage.

Preferred Qualifications

• Bachelor's/Diploma degree in Instrumentation, Electronics, Electrical, Mechanical Engineering or equivalent.
• 5–10 years of relevant calibration experience.
• Experience in pharmaceutical, healthcare, cosmetics, food or other regulated industries.
• Experience working at pharmaceutical manufacturing facilities will be highly preferred.
• Experience with both laboratory and process instrumentation is desirable.

Key Performance Indicators

• Calibration completion within agreed schedule.
• Accuracy and quality of calibration certificates.
• Zero/low documentation errors.
• Timely closure of OOT/deviation investigations.
• Compliance with GMP and client procedures.
• Proper traceability of reference standards.
• Customer satisfaction.
• Productivity and utilization of calibration team.

Personal Attributes

• Strong analytical and problem-solving skills.
• Good technical communication.
• Strong documentation discipline.
• Ability to work independently at client sites.
• Leadership and team-management skills.
• Ability to handle multiple projects and deadlines.
• Professional approach toward clients and regulatory environments.
• Willingness to travel to client sites.

Reporting

Reports To: Calibration Manager / Head – Calibration & Validation

Supervises: Calibration Engineers / Calibration Technicians / Junior Engineers

Work Location: In person