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 position is in Operations at the Lexington location and reports to the Production Supervisor. The schedule is a 12-hour rotating 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.
• 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 and procedures and requirements established by regulatory agencies.
• Perform line clearances, cleaning and sanitization, prepare and sterilize filling equipment, sterilize components, operate aseptic filling equipment, conduct filter testing, and operate vial-washing equipment.
• Operate and maintain production equipment.
• Weigh, measure, and check raw materials to ensure batches contain the correct ingredients and quantities.
• Execute process and equipment validation protocols.
• 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, such as 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