EXPANSION Manufacturing Operator

Piramal Pharma Ltd; Lexington (KY); On-site; USD 25,000 - 33,000; Full time

Job summary

Piramal Pharma Solutions in Lexington is seeking an EXPANSION Manufacturing Operator to join the Operations team. Reporting to the Production Supervisor, you will handle aseptic production steps, line clearances, sterilization, and equipment operation on the night shift in a regulated environment.

The role emphasizes adherence to cGMP, OSHA, and FDA requirements, with responsibilities covering preparation, filling, capping, lyophilization, and process improvements.

Qualifications

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

Responsibilities

• Comply with policies and procedures regulated by PPS and regulators.
• Perform line clearances, cleaning, sterilization of fill equipment and components.
• Operate and maintain production equipment.
• Weigh, measure and verify raw materials for correct ingredients and quantities.
• Execute validation protocols for processes and equipment.
• Maintain clean records and a compliant work environment.
• Read and follow SOPs and provide feedback for improvements.
• Review production documentation for quality and cGMP compliance.
• Provide on‑the‑job training for new operators.
• Collaborate with quality, validation, and supply chain to reach production goals.

Skills

Mechanical aptitude

Operate processing equipment

Regulatory comprehension

Team player

Attention to detail

Reading SOPs

Reliability

Education

High School education or equivalent

2+ years manufacturing experience

Pharmaceutical/aseptic manufacturing preferred

Job description

Division

Piramal Pharma Solutions

For more details, please visit : www.piramalpharmasolutions.com

Job Title

EXPANSION Manufacturing Operator

Job Description

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 activitiesReview 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