Technician, Filling Operations (Onsite)

Technician, Operations. Support drug product development and GMP clinical supply of sterile dosage forms. Partner with formulation development colleagues to further understand and knowledge capture of processes.

Requirements

• Aseptic Processing: Perform sterile filling operations in compliance with Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs).
• Aseptic experience: Experience in working in Grade A environment is required, including aseptic qualification and performing environmental monitoring.
• Isolator Operation: Operate and maintain large complex isolators, ensuring optimal performance and adherence to safety protocols.
• Documentation: Maintain accurate records of inspection results and maintain accurate records of findings in an electronic system.
• GMP: Follow established inspection batch records, protocols and quality standards to ensure compliance with industry regulations.
• Cleanroom Environment: Able to gown and work in Grade C conditions, maintaining good aseptic cleanroom behaviors
• Collaboration: Able to communicate clearly with team and work closely with other teams to ensure on time delivery.
• Training and Compliance: Assist in training new staff on sterile supply procedures and protocols, ensuring adherence to GMP standards.
• Leadership: Able to identify and escalate issues, perform basic troubleshooting, and capturing learnings to improve systems and processes.