Director

2 months ago


San Diego, United States VASTEK GROUP INC Full time

Summary The role is responsible for Cleaning Validation within the Quality Assurance group of a recently built enzyme manufacturing facility serving pharmaceutical customers. This operation is part of our Biosciences Division (BID) part of our Life Sciences Solutions Group (LSG). BID is experiencing outstanding growth supporting exciting markets Academia Research Biotech Pharma Cell and Gene Therapy and Medical Devices. The Cleaning Validation Engineer will be responsible for the execution of cleaning validation activities to support enzyme manufacturing generating and executing cycle development cleaning verification and cleaning validation documentation including protocols final reports deviations and SOPs while ensuring compliance to GMP requirements. Develop and execute cleaning validation protocols to support all required cleaning validation efforts this will include but is not limited to Clean Hold and Dirty Hold cleaning validation activities. Coordinate schedule and execute all cleaning development validation and continuous monitoring/verification activities with appropriate departments. Investigate and troubleshoot problems that occur during cleaning processes. Lead investigations for deviations encountered during the execution of Cleaning Validation and/or continuous monitoring/verification activities and provide documentation to support the findings. Develops and authors change controls for cleaning processes or equipment changes. Write validation plans and risk assessments related to specific projects and facilities. Perform risk assessment



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