Manufacturing Operator

Job Overview

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
• 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
• 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