Manufacturing Operator

Piramal Pharma Ltd; Lexington (KY); On-site; USD 42,000 - 60,000; Full time

Job summary

Piramal Pharma Ltd is seeking a Manufacturing Operator in Lexington for Pharma Solutions. The role reports to the Production Supervisor and handles component preparation, filling, capping, autoclaving, and lyophilization production during night shifts.

Key duties include complying with cGMP, performing line clearances, operating aseptic equipment, and maintaining documentation. Candidates should have high school education and manufacturing experience; aseptic environment preferred.

Qualifications

• High School education or equivalent.
• 2+ years in an industrial/manufacturing environment.
• Pharmaceutical manufacturing and/or aseptic manufacturing environment preferred.
• Mechanical aptitude and ability to operate processing equipment.
• Knowledge of regulatory requirements (cGMP, OSHA, FDA).

Responsibilities

• Consistently comply with policies and procedures including PPS and regulatory agencies.
• Perform line clearances, cleaning/sanitization, sterilization of fill equipment, and operation of aseptic filling equipment.
• Operate and maintain production related equipment.
• Weigh and check raw materials to ensure correct batches.
• Execute validation protocols for processes and equipment.
• Maintain records and a clean environment to comply with regulatory requirements.
• Read and follow Good Manufacturing Practices and SOPs; review and suggest improvements.

Education

High School education or equivalent

Tools

Mechanical aptitude/operating processing equipment

Job description

Job Title

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.

Shift

Nights

Reporting Structure

This position reports to the Production Supervisor.

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