EXPANSION Manufacturing Operator

EXPANSION Manufacturing Operator

Job Description Business:
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
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* Key Responsibilities:

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* • 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
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* Qualifications:

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* • 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