Cleaning Validation Engineer IIIApex Systems is seeking a Cleaning Validation Engineer III for an immediate 12+ month contract opportunity with one of our Fortune 500 Healthcare Clients!Job Description:Duties: Principle Cleaning Validation EngineerManufacturing Engineering contributes to Company by developing manufacturing processes, production floor layouts and associated tools. Reviews new designs for manufacturability. Designs process improvements to reduce product cost, process cycle time and improved product quality.Accountabilities:Responsible for technical support and life-cycle management of the cleaning validation programMaintains a qualified state of cleaning processes and procedures, as well as designing and implementing new cleaning processes.Maintains the site cleaning validation master planConducts risk assessments of existing and new processes, equipment, etc. as it relates to cleaning procedures/validationDesigns and executes cleaning process optimization studies, cleaning verification and cleaning validation studiesManages, schedules, coordinates, and executes cleaning engineering studies to optimize cleaning procedures, cleaning verification studies, and cleaning validation studiesDesigns and develops equipment cleaning proceduresPrepares and executes cleaning protocols and reports for cleaning development and validationInvestigates cleaning failuresSupports the periodic review of cleaning validation studiesDevelops change controls for implementation of cleaning procedure changes as neededTrains manufacturing and QC personnel on cleaning validation protocols and proceduresFollows all certified standards, GMP, OSHA, plant policies and proceduresSkills:Preferred Requirements: 5+ years of experience in pharmaceutical manufacturing industry.
Understanding of FDA regulations surrounding the manufacture of pharmaceuticals and/or medical devices and GMPs. Understanding of cleaning validation principles, including calculations of cleaning limits, equipment swabbing, and continued cleaning process verification within a pharmaceutical or medical device manufacturing environment. Excellent technical writing skills with a thorough understanding of good document practices.What is expected of you and others at this level:Applies comprehensive knowledge and a thorough understanding of concepts, principles, and technical capabilities to perform varied tasks and projects. May contribute to the development of policies and procedures.
Works on complex projects of large scope. Develops technical solutions to a wide range of difficult problems. Solutions are innovative and consistent with organization objectives. Completes work independently receives general guidance on new projects.
Work reviewed for purpose of meeting objectives. May act as a mentor to less experienced colleague.Education: Preferred Requirements: B.S.