Product Technician​/Chemist

Manufacturing Department:
Manufacturing / Production

Note:

1 round In-person interview required.

Responsible for executing and supporting sterile manufacturing and aseptic fill‑finish operations in compliance with cGMP, SOPs, and safety requirements. The role involves production execution, equipment operation, batch documentation, and participation in quality systems within a startup manufacturing environment.

• Perform material requests and transfers (in/out), including weighing and compounding activities.
• Conduct filter integrity testing and washing of used components.
• Prepare, inspect, and pack cleaned components, load and unload items for sterilization.
• Clean, set up, and operate mixing vessels and support VHP generator operations.
• Follow cleanroom gowning procedures and aseptic practices at all times.
• Set up and operate filling, stoppering, and capping equipment.
• Operate sterile manufacturing equipment including rotary washing machines, depyrogenation tunnels, filling and stoppering machines, freeze dryers (lyophilizers) with automatic loading/unloading systems, cap sealing machines, and external washing machines.
• Execute aseptic fill‑finish operations within isolators and operate terminal sterilizers.
• Perform manual and/or automated visual inspection of vials.
• Operate labeling and packaging machines with awareness of serialization requirements.
• Perform daily and periodic cleaning and sanitization of manufacturing areas and equipment.
• Monitor, record, and maintain environmental parameters such as pressure differentials, temperature, and humidity.
• Ensure strict compliance with cGMP, GDP, SOPs, and safety requirements.
• Prepare and accurately complete manufacturing and packaging batch records.
• Support preparation and revision of SOPs and demonstrate awareness of Quality Management System documentation, including change control, deviations, CAPA, investigations, and risk assessments.

• Strong knowledge of aseptic techniques and cleanroom behavior.
• Experience with sterile injectable fill‑finish operations.
• Thorough understanding of cGMP and FDA regulations.