Cleaning validation specialist

Our client, a company firmly etablished, offering ready to use solutions of manufacturing and packaging for the pharmaceutical, nutraceutical, alimentary and cosmetic industries is currently looking for a cleaning validation specialist.

Nature of position

In collaboration with the company management, you will be responsible to validate the cleaning, the monitoring of safety data sheets (MSDS) and the cleaning procedures. In addition, you will also be responsible for the writing and executing of equipment / systems qualification protocols (IQ / OQ / PQ) and processes in accordance with the validation master plan. As such, you will :

• Perform the packaging equipment qualification as well of the system ( compresses air, HVAC, etc.) ;
• Carry out the requalifications according to the master validation plan ;
• Validate the packaging processes ;
• Keep the cleaning matrix up to date ;
• Prepare and review the validation files of the cleaning products ;
• Prepare and review the worst case customer product validation files ;
• Organize and perform the worst case verification samples ;
• Contact the customers for their technical support in terms of analysis methods of targeted products ;
• Ensure the technology tranfer of the validated methods towards a certified laboaratory ( if applicable) ;
• Analyse the results and issue the reports ;
• Evaluate the needs in personal protection equipement from products safety data sheets (MSDS) and issue recommendations for the production ;
• Evaluate the feasibility of the products ;
• Ensure the follow-up of the BPF during validations activities and operations in general and initiate change notices if needed or report the differences to the AQ group in order to initiate CAPA ;
• Initiate and carry out the follow-up of the change control notices for equipments and qualified systems that required a partial or complete revalidation ;
• Perform every other task compatibles with your functions.

Required qualification

• Bachelor in sciences (chemistry, biology, biochemistry, etc.), engineering or any other related field ;
• Minimum 5 years of experience in the equipments validation, processes and cleaning field ;
• Bilingual in french and english, written and spoken ;
• Proeficient in pharmaceuticals standards in effect (BPF/GMP’s, FDA et Santé Canada) ;
• Knowledges of ISO and HACCP quality concepts.

Education / training

Bachelor (others), Bachelor in biochemistry, Bachelor in biology, Bachelor in chemistry

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