Aseptic Filling Specialist: Cleanroom & Sterilization

SmartRecruiters, Inc.; San Dimas (CA); On-site; USD 52,000 - 72,000; Full time

Job summary

SmartRecruiters, Inc. is seeking a manufacturing operator in a GMP environment to perform routine aseptic processing and related tasks on the production line in California.

You will follow established SOPs and Master Batch Records while ensuring compliance with cGMP standards. Responsibilities include operating sterilization and packaging equipment, maintaining equipment cleanliness, and completing required documentation.

Qualifications

• Follows Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMPs).
• Performs basic aseptic processing and related routine manufacturing tasks.

Responsibilities

• Works on basic assignments following established SOPs, Master Batch Records and cGMPs.
• Reports to Team Lead on line performance and escalates issues as needed.
• Performs basic troubleshooting and escalation when required.
• Organizes routine tasks effectively.
• Prepares equipment and components for sterilization.
• Operates processing equipment including autoclaves, ovens, vial washers, and depyrogenation tunnel.
• Cleans and assembles/disassembles equipment for production.
• Performs clean-in-place and sterilization-in-place of tanks.
• Performs annealing and sterile filtrations of products.
• Operates vial capper and handles lyophilizer outputs.
• Performs Basic Oracle and MES transactions.
• Cleans manufacturing areas and documents events and tasks.
• Reports variance or deviation from SOPs to management.
• Prepares coating solutions.

Job description

SmartRecruiters, Inc. is seeking a manufacturing operator in a GMP environment to perform routine aseptic processing and related tasks on the production line in California.

You will follow established SOPs and Master Batch Records while ensuring compliance with cGMP standards. Responsibilities include operating sterilization and packaging equipment, maintaining equipment cleanliness, and completing required documentation.