The Manufacturing Operator performs production related activities, including component preparation, filling, capping, autoclaving, terminal sterilization, compounding, and lyophilization production.
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
High School education or equivalent
2+ years' working within an industrial or manufacturing environment
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