Manufacturing Operator

Piramal Pharma • Lexington, KY

1d

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’ Lexington location and reports to the Production Supervisor. The position works the night shift.

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.
• Knowledge of, or ability to understand and follow, job-related regulatory requirements such as cGMP, OSHA, and FDA requirements.
• Ability to read, interpret, and follow written instructions.
• Team-oriented approach, commitment to quality, and ability to work effectively with others.
• Consistent attendance and overall reliability.

Nice To Haves

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

Responsibilities

• Comply consistently with applicable policies and procedures, including those governed by PPS and regulatory agencies.
• Perform line clearances, cleaning and sanitization, prepare and sterilize filling equipment, sterilize components, operate aseptic filling equipment, perform filter testing, and operate vial-washing equipment.
• Operate and maintain production-related equipment.
• Weigh, measure, and check raw materials to ensure batches contain the proper ingredients and quantities.
• Execute validation protocols for processes and equipment.
• Maintain records and a clean environment in compliance 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, such as batch records and logbooks, 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 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