Aseptic filling -Manufacturing

Integrated Resources 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

• Works on basic assignments following established Standard Operating Procedures (SOPs), Master Batch Records and current Good Manufacturing Practices (cGMPs). Performs routine tasks associated with aseptic processing, dispensing, compaction, granulation, milling and coating.
• Reports to Team Lead on a regular basis on line performance and report any issues that need to be resolved.
• Performs basic troubleshooting of issues and escalates when required.
• Organizes routine tasks in an effective manner.
• Prepares equipment and components for sterilization.
• Operates processing equipment including autoclaves, ovens, vial washers, and depyrogenation tunnel.
• Cleans (manually and clean-in-place), assembles and disassembles equipment for production.
• Performs clean-in-place and sterilization-in-place of tanks.
• Performs annealing and sterile filtrations of products.
• Operates vial capper, unloads product from lyophilizers, and packs off unloaded vials from lyophilizers and liquid fill line.
• Performs Basic Oracle and MES (Manufacturing Execution System) transactions.
• Cleans manufacturing areas, including walls, ceilings and floors.
• Accurately completes required documentation of events and tasks related to assigned work, including logbooks, batch records, etc.
• Reports variance or deviation from standard procedures to department management.
• Prepares coating solution.

Additional Information

All your information will be kept confidential according to EEO guidelines.