Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer, better lives. Our purpose as a company is to discover and develop therapies that will change the course of human health. We value our passion for patients, quest for innovation, spirit of independence and love of challenge. With a presence in more than 70 countries, and growing - we look for talented people to grow our business, advance our science and contribute to our unique culture.
Celgene International Headquarters are located in Boudry (NE) and an additional manufacturing plant is being built in Couvet (NE) to support our growth. This site will primarily be dedicated to the manufacturing of solid dosage form products for patients in worldwide markets. The Senior Calibration Specialist is responsible for the calibration activities at the Couvet Manufacturing site.
This role assures compliance of these activities with cGMP as well as with internal policies and procedures. The Senior Calibration Specialist shall lead the Calibration team in their activities.
Duties and Responsibilities
a. Determine the calibration requirements of measuring instruments.
b. Ensure measuring instruments across the site, including QC, production & warehouse, facilities, utilities & equipment, are calibrated and maintained in compliance with local policies, guidelines, and procedures during their lifecycle.
c. Plan calibration activities with equipment owners.
d. Execute calibrations, documenting the calibration performed in the calibration management software.
e. Update calibration lifecycle documentation, including the introduction of new instruments, modifications of parameter, change of status and decommissioning. f. Effectively communicate the status of all instruments requiring calibration. Ensure calibration tags are up to date and reflect the status of the calibration.
g. Order and supervise external vendors for calibration.
h. Management of calibration standards required to execute calibration activities.
i. Develop and update written procedures for calibration activities.
j. Assist in troubleshooting of measuring instruments. Conduct investigations and coordinate activities together with line functions to follow-up through defect resolution.
k. Document and communicate calibration related out of tolerances and deviations appropriately.
l. Follow through with deviation resolution, including initiating and following change requests and CAPAs related to measuring instruments.
m. Support activities related to measuring instruments, such as adjustment, set up, replacement, modification, maintenance, installation of new equipment, etc.
n. Develop and justify calibration approach based on risk and a scientific rational
• 5+ years experience in calibration
• BS in Engineering or Technical discipline
• Competent at determining the calibration requirements of measuring instruments
• Leadership abilities including demonstrated coaching and training skills
• Experienced at calibrating instruments, e.g. temperature, humidity, speed, pressure, weight, flow rates, etc.
• Familiar with calibration standards, cGMP and Good Documentation Practices
• Team player
• Good communication skills in French and English
• Knowledge of pharmaceutical (solid dosage) facilities is advantageous
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Celgene is a global biopharmaceutical company committed to improving the lives of patients worldwide. At Celgene, we seek to deliver truly innovative and life-changing treatments for our patients.