EXPANSION Manufacturing Operator

Piramal Pharma • Lexington, KY

3d

About The Position

The Manufacturing Operator performs production-related activities, including component preparation, filling, capping, autoclaving, terminal sterilization, compounding, and lyophilization production. The role is in Operations at Piramal Pharma Solutions in Lexington and reports to the Production Supervisor. The position works 12-hour rotating shifts.

Requirements

• High school education or equivalent.
• At least 2 years of experience working in an industrial or manufacturing environment.
• Mechanical aptitude and ability to operate processing equipment.
• Prior knowledge of or ability to understand and follow job-related regulatory requirements, including cGMP, OSHA, and FDA requirements.
• Ability to read, interpret, and follow written instructions.
• Team-oriented approach and commitment to quality and effective collaboration.
• Consistent attendance and overall reliability.

Nice To Haves

• Experience in pharmaceutical manufacturing and/or an aseptic manufacturing environment.

Responsibilities

• Comply with applicable company policies, procedures, and regulatory requirements.
• Perform line clearances and cleaning and sanitization activities; prepare and sterilize fill equipment and components; operate aseptic filling and vial-washing equipment; and perform filter testing.
• Operate and maintain production-related equipment.
• Weigh, measure, and check raw materials to ensure batches contain the correct ingredients and quantities.
• Execute validation protocols for processes and equipment.
• Maintain records and a clean environment in accordance 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 related documentation.
• Review completed production documentation, including batch records and log books, for quality and cGMP compliance.
• Initiate appropriate action when process deviations occur.
• Provide on-the-job training for new and developing operators.
• Perform housekeeping assignments and maintain the cleanliness and routine maintenance of the work area and equipment.
• Collaborate and communicate with quality, validation, supply chain, and other functional groups to help achieve production goals.

What This Job Offers

• Job Type: Full-time
• Education Level: High school or GED