Celgene Calibration & Requalification Specialist in Couvet, Switzerland
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.
Temporary position - 12 month
The Calibration & Requalification technician contributes to calibration & requalification activities in the Couvet production site. He assures compliance of these activities with cGMP as well as with internal policies and procedures. The Calibration & Requalification Technician is authorized to direct internal and external work done in this field.
Formation technical discipline (CFC or equivalent).
Knowledge of international cGxP regulations, and good documentation practices.
Experience in pharmaceutical industry.
Ability to perform calibration & requalification of manufacturing and QC equipment.
Ability to manage external suppliers.
Good knowledge in ReQualification of cleanrooms, HVAC systems
Duties and Responsibilities
Execute, document calibration and requalification for all equipment and systems across the site, including QC, production, warehouse, facilities, utilities etc.
Ensure measuring instrument and requalified equipment, systems are calibrated and requalified and maintained in compliance with local policies, guidelines, and procedures during their lifecycle.
Update calibration and requalification documentation according to equipment lifecycle: introduction of new equipment, modification of parameter, change of status etc.
Effectively communicate the status of all instruments requiring calibration and requalification.
Ensure that all tags are up to date and reflect the status of the calibration and requalification.
Plan calibration and requalification activities with equipment owners. Ordered and supervised external vendor for calibration and requalification.
Develop and update written procedures for calibration and requalification activities.
Assist in troubleshooting of measuring instrument and requalified equipment.
Conduct investigations and coordinate activities together with line functions to follow-up through defect resolution.
Record and document any calibration and requalified equipment related out of tolerance and deviation into the appropriate software.
Initiate and follow up the change request and CAPA related to measuring instrument and requalified equipment.
Performed and support activities on measuring instruments and requalified equipment such as adjustment, setting, replacement, modification, maintenance, installation of new equipment etc. Together with line functions to follow-up through defect resolution.
Develop and justify calibration and requalification approach based on risk and a scientific rational.
Document calibration and requalification performed in calibration and requalification management software. Reviewing cGMP calibration and requalification document.
COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE
At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients. Our vision as a company is to build a major global biopharmaceutical corporation while focusing on the discovery, the development, and the commercialization of products for the treatment of cancer and other severe, immune, inflammatory conditions.
“At Celgene, we seek to deliver truly innovative and life-changing drugs for our patients.”
There are more than 300 clinical trials at major medical centers using compounds from Celgene. Investigational compounds are being studied for patients with incurable hematological and solid tumor cancers, including multiple myeloma, myelodysplastic syndromes, chronic lymphocytic leukemia (CLL), non-Hodgkin’s lymphoma (NHL), triple-negative breast cancer and pancreatic cancer. As committed as we are to clinical accomplishment, we are equally committed to patient support, which is a guiding principle at Celgene. We believe all who can benefit from our discoveries should have the opportunity to do so. Celgene puts patients first with industry-leading programs that provide information, support and access to our innovative therapies.
Celgene is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Celgene complies with all applicable national, state and local laws governing nondiscrimination in employment as well as employment eligibility verification requirements of the Immigration and Nationality Act. All applicants must have authorization to work for Celgene in the U.S.COMMITTED TO IMPROVING THE LIVES OF PATIENTS WORLDWIDE