Production Chemist

Overview

Job Title
:
Production Chemist – Sterile / Injectable Manufacturing (Vial Filling)

Position Summary

The Production Chemist / Production Technician is responsible for executing sterile manufacturing and aseptic vial filling operations in a controlled cleanroom environment. The role requires strict adherence to cGMP regulations, SOPs, and safety standards to ensure product quality and regulatory compliance throughout sterile fill-finish operations.

• Perform material requests, material transfers, weighing, and compounding activities in accordance with approved procedures.
• Conduct filter integrity testing and component washing activities per validated processes.
• Prepare, inspect, assemble, and load components and materials for sterilization.
• Clean, set up, and operate mixing vessels and provide operational support for VHP generator activities.
• Follow aseptic techniques and cleanroom gowning procedures at all times to maintain contamination control.
• Set up, operate, and monitor aseptic vial filling lines, including filling, stoppering, and capping operations.
• Operate and monitor sterile manufacturing equipment such as rotary washers, depyrogenation tunnels, filling machines, lyophilizers, terminal sterilizers, and packaging equipment.
• Execute aseptic fill-finish operations within isolators or restricted access barrier systems (RABS).
• Perform both manual and automated visual inspection of filled vials to ensure product quality.
• Monitor and document environmental conditions including temperature, humidity, and pressure differentials.
• Accurately complete manufacturing and packaging batch records and associated documentation in compliance with cGMP requirements.
• Support SOP revisions, deviation investigations, CAPA activities, and change control processes as required.

• Strong hands-on experience with aseptic vial filling and sterile injectable manufacturing operations.
• Proven experience with filling, stoppering, capping, and visual inspection of sterile products.
• Solid understanding of cGMP regulations, FDA requirements, and cleanroom behavior.
• Excellent documentation skills with demonstrated experience completing batch records and manufacturing documentation.
• Ability to work effectively in a fast-paced, highly regulated cleanroom environment.

• Bachelor’s degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline.