Manufacturing Operator

Piramal Enterprises - Lexington, KY

Full-time - Entry Level

Lexington, KY

Securities, Commodity Contracts, and Other Financial Investments and Related Activities

About the position

This is a night shift position that works a 12-hour rotating schedule. The Manufacturing Operator performs production-related activities, including component preparation, filling, capping, autoclaving, terminal sterilization, compounding, and lyophilization production.

Responsibilities

• Consistently comply with all applicable policies and procedures, including those regulated by PPS and various regulatory agencies
• Perform 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

Requirements

• High School education or equivalent
• 2+ years' working within an industrial or manufacturing environment
• Pharmaceutical manufacturing and/or aseptic manufacturing environment preferred