EXPANSION - Manufacturing Operator

Expansion - Manufacturing Operator

Business: Pharma Solutions

Department: Operations (OPS)

Location: Lexington

Job Overview

Reporting to the Production Supervisor, the Manufacturing Operator performs production related activities, including component preparation, filling, capping, autoclaving, terminal sterilization, compounding, and lyophilization production.

Reporting Structure

This position reports to the Production Supervisor.

Shift:

Nights

Key Responsibilities:

Consistently comply with all applicable policies and procedures, including those regulated by PPS and various regulatory agencies

Performs line clearances, cleaning/sanitization, cleaning, preparing and sterilization of fill equipment, sterilization of components, operation of aseptic filling equipment, filter testing, operation vial washing equipment

Operate and maintain production related equipment

Weigh, measure and check raw materials to assure batches manufactured contain proper ingredients and quantities

Execute validation protocols for processes and equipment

Maintain records and a clean environment to comply 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 corresponding documentation activities

Review completed production documentation (batch records, log books, etc.) for quality and cGMP compliance

Initiate appropriate action when process deviations occur

Perform on-the-job training for new and developing operators

Routinely perform housekeeping assignments, maintain cleanliness and routine maintenance of the work area and equipment

Collaborate effectively and communicate with other functional groups, including: quality, validation, supply chain to ensure production goals are achieved

Qualifications:

High School education or equivalent

2+ years' working within an industrial or manufacturing environment

Pharmaceutical manufacturing and/or aseptic manufacturing environment preferred

Mechanical aptitude, ability to operate processing equipment

Prior knowledge and/or ability to understand and follow job related regulatory requirements (cGMP, OSHA, FDA)

Ability to read, interpret, and follow written instructions

Team player committed to quality and working effectively with others

Track record of consistent attendance and overall reliability