EXPANSION Manufacturing Operator
About The Position
The Manufacturing Operator performs production-related activities for Pharma Solutions, including component preparation, filling, capping, autoclaving, terminal sterilization, compounding, and lyophilization production. The position is based in Lexington and reports to the Production Supervisor. The schedule is a 12-hour rotating day shift. The operator works in accordance with applicable company and regulatory requirements, maintains production equipment and records, reviews production documentation, and collaborates with other functional groups to help meet production goals.
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 established 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 validation protocols for processes and equipment.
- Maintain records and a clean environment in compliance with regulatory requirements.
- Read, understand, and follow 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 to 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.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Entry Level
Education Level
High school or GED
