Manufacturing Operator - Day Shift at Piramal

Lexington, Kentucky, United States -

Full Time

Start Date

Immediate

Expiry Date

04 Jan, 26

Salary

0.0

Posted On

06 Oct, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Mechanical Aptitude, Regulatory Compliance, Good Manufacturing Practices, Team Player, Quality Assurance, Process Improvement, Documentation, Equipment Operation, Housekeeping, Communication, Training, Troubleshooting, Aseptic Techniques, Component Sterilization, Batch Record Review, Raw Material Handling

Industry

Financial Services

Description

Business: Pharma Solution Department: Operations Location: Lexington Job Overview The Manufacturing Operator performs production related activities, including component preparation, filling, capping, autoclaving, terminal sterilization, compounding, and lyophilization production. Reporting Structure Directly reports to Manufacturing Supervisor Key Responsibilities 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 Education Requirements • High School education or equivalent Experience • 2+ years’ working within an industrial or manufacturing environment • Pharmaceutical manufacturing and/or aseptic manufacturing environment preferred Competencies 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

Responsibilities

The Manufacturing Operator performs production-related activities including component preparation, filling, capping, and sterilization. They ensure compliance with regulatory requirements and maintain a clean environment while operating production equipment.