EXPANSION Manufacturing Operator

Piramal Pharma Ltd•Lexington, KY

4d•Onsite

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 schedule is days on a 12-hour rotating schedule.

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 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 with applicable company policies and procedures and requirements set by regulatory agencies.
Perform line clearances, cleaning and sanitization, prepare and sterilize fill equipment, sterilize components, operate aseptic filling equipment, conduct 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 process and equipment validation protocols.
Maintain records and a clean environment to meet 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 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 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.