Aseptic Manufacturing Team Lead

Piramal Critical Care, Inc.; Lexington (KY); On-site; USD 70,000 - 95,000; Full time

Job summary

Piramal Pharma Solutions in Lexington, KY, is seeking a Manufacturing Team Lead to act as the on-the-floor resource for manufacturing operators, overseeing aseptic processes and advanced production steps. You will guide daily operations, ensure documentation accuracy, and maintain cGMP compliance.

The role reports to the Production Supervisor, with responsibilities spanning process checks, setup, troubleshooting, training, and ensuring a clean, compliant manufacturing environment.

Qualifications

• High School education or equivalent.
• Minimum 2 years of experience in an aseptic, or other cGMP pharmaceutical manufacturing environment.
• Ability to communicate effectively and lead a team.
• Mechanical aptitude and ability to operate processing equipment.
• Knowledge of regulatory requirements (cGMP, OSHA, FDA).
• Ability to read, interpret, and follow written instructions.
• Team player with reliability and consistent attendance.

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

Team leadership

Communication

Mechanical aptitude

Regulatory knowledge (cGMP/OSHA/FDA)

Reading/writing instructions

Education

High School degree or equivalent

Job description

Piramal Pharma Solutions in Lexington, KY, is seeking a Manufacturing Team Lead to act as the on-the-floor resource for manufacturing operators, overseeing aseptic processes and advanced production steps. You will guide daily operations, ensure documentation accuracy, and maintain cGMP compliance.

The role reports to the Production Supervisor, with responsibilities spanning process checks, setup, troubleshooting, training, and ensuring a clean, compliant manufacturing environment.