Instrumentation Engineer, CDMO
Lambda Therapeutic Research
Ahmedabad, Gujarat, India1h agovia LinkedIn
Key Responsibilities
- Perform preventive and breakdown maintenance of major analytical, cell culture, and R&D equipment including LC-MS, HPLC, and UPLC systems.
- Perform preventive and breakdown maintenance of biopharma process, laboratory, containment, sterilization, and filling equipment which include but not limited to:
- Chromatography purification systems
- UF/DF and TFF systems
- Bioreactors
- Ensure high availability and reliability of all equipment with minimal downtime.
- Maintain critical spares, consumables, and accessories required for preventive maintenance and emergency breakdowns.
- Prepare and maintain SOPs, PM checklists, calibration support documents, deviation investigations, RCA reports, and instrument documentation in line with QMS requirements.
- Plan, execute, and track preventive maintenance and calibration schedules for all instruments.
- Support and coordinate calibration activities with user departments.
- Coordinate AMC and OEM service visits, ensuring timely execution and proper documentation.
- Support equipment qualification, requalification, and audit readiness for GMP/GLP inspections.
- Support inventory management activity related to GMP instruments.