EXPANSION Manufacturing Operator

EXPANSION Manufacturing OperatorJob DescriptionBusiness: Pharma Solutions Department: Operations (OPS) Location: Lexington**Job Overview**Reporting to the Production Supervisor, the Manufacturing Operator performs production related activities, including component preparation, filling, capping, autoclaving, terminal sterilization, compounding, and lyophilization production.**Reporting Structure**This position reports to the Production Supervisor.**Shift:**Nights**Key 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 achieved**Qualifications:**• High School education or equivalent• 2+ years’ working within an industrial or manufacturing environment • Pharmaceutical manufacturing and/or aseptic manufacturing environment preferred • 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 #J-18808-Ljbffr Piramal Pharma Limited