Job Description
Key Responsibilities
Perform preventive, predictive, and breakdown maintenance of HPLC systems.
Install, commission, configure, and qualify new HPLC instruments and associated software.
Troubleshoot hardware, software, and chromatography-related issues to minimize downtime.
Execute IQ, OQ, and support PQ activities for HPLC instruments.
Coordinate with OEM service engineers for major repairs, AMC activities, and technical support.
Maintain instrument calibration schedules and ensure timely execution.
Prepare and review maintenance records, calibration reports, service logs, SOPs, and equipment history files.
Ensure compliance with cGMP, GLP, ALCOA+, 21 CFR Part 11, and data integrity requirements.
Support internal, customer, and regulatory audits by providing instrument-related documentation.
Maintain adequate inventory of critical spare parts and consumables....