Expansion Manufacturing Operator - Night Shift

Piramal Pharma Solutions Inc.; Lexington (KY); On-site; USD 42,000 - 66,000; Full time

Job summary

Piramal Pharma Solutions Inc. in Lexington is expanding its OPS team. The EXPANSION Manufacturing Operator will perform production activities such as preparation, filling, capping, autoclaving, terminal sterilization, compounding and lyophilization.

Shift: Nights. Reports to the Production Supervisor. The role requires strict adherence to GMP, SOPs and regulatory guidelines, with duties including line clearances, equipment sterilization, material weighing, and batch documentation.

Qualifications

• High school education or equivalent.
• 2+ years in an industrial or manufacturing environment preferred.
• Pharmaceutical manufacturing and/or aseptic manufacturing experience preferred.
• Mechanical aptitude and ability to operate processing equipment.
• Ability to read and follow regulatory requirements (cGMP, OSHA, FDA).
• Team player with reliability and good attendance.

Responsibilities

• Consistently comply with all applicable policies and procedures, including PPS and 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 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.

Skills

Mechanical aptitude

Team player

Reading & following instructions

Education

High School education or equivalent

Job description

Piramal Pharma Solutions Inc. in Lexington is expanding its OPS team. The EXPANSION Manufacturing Operator will perform production activities such as preparation, filling, capping, autoclaving, terminal sterilization, compounding and lyophilization.

Shift: Nights. Reports to the Production Supervisor. The role requires strict adherence to GMP, SOPs and regulatory guidelines, with duties including line clearances, equipment sterilization, material weighing, and batch documentation.