Scientific Instrument Specialist

Job Purpose:

To ensure laboratory instruments operate effectively and efficiently. This involves implementing calibration, preventive maintenance, and maintenance activities to meet regulatory requirements.

• Main Responsibilities

• Perform and follow up the calibration of analytical instruments such as UHPLC with various detectors (UV, DAD, RI, FL and CAD), LC-MS/MS, IC, ICP-MS, GC, DSC, X-Ray, UV-Spectrophotometer, Dissolution systems, and analytical balances according to SOP's, cGMPs, and established regulatory requirements.
• Maintain and update records of calibrated instruments within the Analytical Research function.
• Follow up on the preventive maintenance, maintenance, and housekeeping of laboratory instruments.
• Prepare calibration and preventive maintenance schedules and keep them updated.
• Collaborate with Engineering to maintain equipment validation procedures to current standards.
• Enter calibration events with data into the Equipment Management Database (SAP).
• Prepare equipment for qualification studies and execute qualification and validation studies according to approved protocols and SOPs.
• Coordinate with others to prepare and approve risk assessment, change control, and qualification files.
• Perform mapping for refrigerators, freezers, and controlled areas.
• Address instrument or software failure and implement corrective action.
• Identify and request required spare parts, devices, and preventive maintenance kits related to qualification procedures.
• Contact service providers for qualification and maintenance services.
• Adhere to safety measures throughout work.
• Follow up on sent items (data loggers, thermometers, stopwatches) for calibration to accredited institutions.