Manufacturing Operator
: Job Details :

Business: Pharma SolutionDepartment: Pharmaceutical ProductionLocation: LexingtonJob OverviewThis is a night shift positions that work a 12 hour rotating schedule.The Manufacturing Operator performs production related activities, including component preparation, filling, capping, autoclaving, terminal sterilization, compounding, and lyophilization production.Reporting StructureReports to Director Technical OperationsKey Responsibilities* Consistently comply with all applicable policies and procedures, including those regulated by PPS and various regulatory agencies* Performs line clearances, cleaning/sanitization, cleaning, preparing and sterilization of fill equipment, sterilization of components, operation of aseptic filling equipment, filter testing, operation vial washing equipment* Operate and maintain production related equipment* Weigh, measure and check raw materials to assure batches manufactured contain proper ingredients and quantities* Execute validation protocols for processes and equipment* Maintain records and a clean environment to comply with regulatory requirements* Read, understand, and comply with Good Manufacturing Practices and Standard Operating Procedures.* Review current SOPs and provide feedback on potential process improvements* Participate in troubleshooting and process improvement activities including corresponding documentation activities* Review completed production documentation (batch records, log books, etc.) for quality and cGMP compliance* Initiate appropriate action when process deviations occur* Perform on-the-job training for new and developing operators* Routinely perform housekeeping assignments, maintain cleanliness and routine maintenance of the work area and equipment* Collaborate effectively and communicate with other functional groups, including: quality, validation, supply chain to ensure production goals are achievedQualification* High School education or equivalentExperience* 2+ years' working within an industrial or manufacturing environment* Pharmaceutical manufacturing and/or aseptic manufacturing environment preferredCompetencies* Mechanical aptitude, ability to operate processing equipment* Prior knowledge and/or ability to understand and follow job related regulatory requirements (cGMP, OSHA, FDA)* Ability to read, interpret, and follow written instructions* Team player committed to quality and working effectively with others* Track record of consistent attendance and overall reliability