Manufacturing Operator

Business: Pharma Solutions

Department: Operations

Location: Lexington

Job Overview

The Manufacturing Operator performs production related activities, including component preparation, filling, capping, autoclaving, terminal sterilization, compounding, and lyophilization production.

Reporting Structure Directly reports to Manufacturing Supervisor
   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

  Education Requirements •    High School education or equivalent   Experience

•     2+ years’ working within an industrial or manufacturing environment
•     Pharmaceutical manufacturing and/or aseptic manufacturing environment preferred

Competencies

•    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