Calibration & Validation Engineer

3 weeks ago

Thane, India Sierra Instrumentation & Controls Full time

Position: Calibration & Validation Engineer (Equipment's)

Location: Thane / On Site within India

Education: Diploma or Bachelor's degree in Engineering (Electronics, Instrumentation) or a related field.

Experience: 1–2 years of experience in autoclave validation or related roles in the pharmaceutical/healthcare industry.


Validation Activities:

  • Conduct thermal mapping and validation of autoclaves using equipment like Kaye Validator or equivalent tools.
  • Perform temperature and pressure distribution studies, biological indicator tests, and load validations.
  • Execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.


Equipment Calibration and Maintenance:

  • Ensure all validation instruments (sensors, thermocouples, data loggers, etc.) are calibrated and functional.
  • Troubleshoot and resolve minor issues with autoclaves and validation equipment.


Documentation and Reporting:

  • Prepare and maintain validation protocols, summary reports, and compliance documentation.
  • Ensure documentation meets regulatory and quality management standards (e.g., GMP, FDA, EU).


Regulatory Compliance:

  • Ensure all activities comply with industry standards such as GAMP, ISO 13485, FDA 21 CFR Part 11, or EU Annex 11.
  • Support audits and inspections by providing validation records and addressing queries.


Coordination and Communication:

  • Coordinate with QA, manufacturing, and maintenance teams to plan validation schedules.
  • Communicate findings and recommend improvements for sterilization processes.


Skills:

  • Strong technical understanding of sterilization processes and autoclave operations.
  • Proficiency in using validation equipment and analyzing thermal mapping data.
  • Excellent documentation and reporting skills.
  • Familiarity with regulatory guidelines and standards.
  • Good communication and teamwork skills.


Work Environment:

  • May require working in controlled environments (cleanrooms) and handling sensitive equipment.
  • Travel to client sites for on-site validation activities may be necessary.


#ITIJobs #Diploma #AutoclaveValidation #equipmentvalidation

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