EXPANSION - Manufacturing Operator

Piramal Pharma Ltd; Lexington (KY); On-site; USD 40,000 - 55,000; Full time

Job summary

Piramal Pharma Ltd in Lexington is seeking a Manufacturing Operator. This role involves performing production activities such as filling, capping, and sterilization, ensuring compliance with GMP and regulatory standards.

The ideal candidate should have a high school education and at least 2 years of experience in an industrial or manufacturing environment, with pharmaceutical or aseptic manufacturing experience preferred.

Qualifications

• 2+ years’ experience in an industrial or manufacturing environment.
• Experience in pharmaceutical or aseptic manufacturing is preferred.
• Ability to read and interpret written instructions.

Responsibilities

• Perform production activities including component preparation and filling.
• Maintain records and ensure compliance with GMP and SOPs.
• Collaborate with quality and supply chain teams to meet production goals.

Skills

Mechanical aptitude

Ability to operate processing equipment

Team player

Knowledge of cGMP and regulatory requirements

Education

High School education or equivalent

Job description

Job Title

EXPANSION - Manufacturing Operator

Business

Pharma Solutions

Department

Operations (OPS)

Location

Lexington

Shift

Nights

Reporting Structure

This position reports to the Production Supervisor.

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.

Key Responsibilities

• Consistently comply with all applicable policies and procedures, including those regulated by PPS and various regulatory agencies.
• Perform line clearances, cleaning/sanitization, preparation and sterilization of fill equipment, sterilization of components, operation of aseptic filling equipment, filter testing, and operation of 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.