Lyophilization Operator I

Fresenius Kabi US•Melrose Park, IL

73d•$27

About The Position

Responsible for initiating, monitoring and executing the lyophilization cycle for all lyophilized products and initiating, monitoring and executing the Terminal Sterilization cycle for all terminally sterilized products. Responsibility includes but not limited to: preparation of the equipment, operating manual and automatic mechanical systems, executing computer driven programs, troubleshooting equipment, unloading product, maintaining cGMP's and work with other departments to meet timelines in the production environment.

Responsibilities

Operates mechanical equipment to execute each specific product code lyophilization / Terminal Sterilization cycle.
Works in an aseptic environment to unload, clean and setup the lyophilizer based on the current Production schedule.
Ensures documentation is accurate and complete for each lyophilization / Terminal Sterilization cycle.
Monitors the lyophilization cycle by calculating hold times, advancing the cycle through the required steps, observing equipment conditions and adjusting as necessary and documenting on appropriate paperwork.
Monitors the Terminal Sterilization cycle by through the required steps, observing equipment conditions and documenting on appropriate paperwork.
Troubleshoots mechanical equipment in response to alarms and mechanical failure.
Utilizes computer systems to perform equipment sanitization, integrity tests and obtain specific product data.
Ensures equipment meets operating specifications for calibration, maintenance and validation.
Provides feedback to supervisor and peers about cycle status, equipment condition, and other operational issues that would affect the production schedule or relate to continuous improvement.
Performs required microbial monitoring when working in the Aseptic environment.
Maintains compliance with company policies, cGMP's, safety, and good housekeeping practices.
Assists as necessary during calibrations, PM's, audits, inspections, and new product protocols.
Forklift operator for Terminal Sterilization production.