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Calibration & Validation Engineer

1 month 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.
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