Aseptic Manufacturing Team Lead - Night Shift

Piramal Pharma Ltd; Lexington (KY); On-site; USD 60,000 - 90,000; Full time

Job summary

The Manufacturing Team Lead position at Piramal Pharma Solutions in Lexington oversees on-the-floor production activities, guiding operators through aseptic processes, filling, capping, and sterilization. You will ensure GMP compliance, maintain records, and coordinate training and shift activities.

Reporting to the Production Supervisor, you’ll manage night shifts, verify batch records, and drive continuous improvement while upholding safety and quality standards in a cGMP environment.

Qualifications

• Minimum 2 years of aseptic or cGMP pharmaceutical manufacturing experience.
• Ability to communicate effectively and lead a team.
• Ability to read, interpret, and follow written instructions.

Responsibilities

• Assists operators by accurately checking processes and tasks or setting-up, trouble-shooting and product change-overs
• Ensure housekeeping activities are completed, ensure cleanliness and orderliness of manufacturing area at all times
• Ensure correctness of team’s manufacturing documentation
• Coordinate and provide on-the-job training to new hires
• Perform end-of-shift reports, as needed
• 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.
• Assists operators by accurately checking processes and tasks or setting-up, trouble-shooting and product change-overs
• Monitor and may perform daily operations and provide direction to staff as needed to maintain safe and cGMP compliant work environment.
• Monitor batch production records and documentation entries throughout the manufacturing/packaging/inspection process to ensure timely closure.
• Helps to ensure compliance with all government and company regulatory requirements to ensure applications of cGMP compliance with respect to staff, areas, documentation, and quality requirements.
• Other duties as assigned

Skills

Communication & leadership

Mechanical aptitude

Regulatory knowledge

Team player

Education

High School education or equivalent

Job description

The Manufacturing Team Lead position at Piramal Pharma Solutions in Lexington oversees on-the-floor production activities, guiding operators through aseptic processes, filling, capping, and sterilization. You will ensure GMP compliance, maintain records, and coordinate training and shift activities.

Reporting to the Production Supervisor, you’ll manage night shifts, verify batch records, and drive continuous improvement while upholding safety and quality standards in a cGMP environment.