Senior Technician, Filling Operations (Onsite)

Senior Technician, Filling Operations (Onsite) position is responsible for hands-on processing activities in sterile filling and lyophilization, and capping. The role requires adherence to GMP procedures, strong attention to detail, and proficiency in electronic systems. The position is based in Rahway, NJ and requires 100% on-site work.

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
• Schedule Adherence: Understands schedule adherence impact and communicates risk
• Compliance: Identifies and addresses compliance, environmental, safety, and process deviations as appropriate while notifying management

Benefits

• Health insurance
• Retirement plan
• Paid time off
• Flexible work arrangements