Lyophilization Operator - 3rd Shift

Fresenius Kabi•Grand Island, NY

1d•Onsite

About The Position

Responsible for overall lyophilization activities. Must be able to perform high level - Clean Room activities while gowned per site SOP. Responsible for loading, unloading, cleaning, sanitization, and preparation of lyophilizers. Must be able to perform assigned tasks for antineoplastic products, including wearing a respirator. This includes initial and ongoing certification. Responsible for initiating, monitoring, and troubleshooting lyophilization cycles. Responsible for daily and weekly cleaning requirements. Ensure all batch documentation is completed properly per cGMPs. Adheres to SOPs, cGMPs, and Safety Requirements. Operates and maintains Line 10 per SOP and regulatory requirements, including set-up, changeover, adjustments, and minor repairs to capping and vial wash machines. Strictly adheres to Aseptic Technique Requirements and proper aseptic technique. Works closely with maintenance to quickly resolve mechanical issues. Assumes other duties and responsibilities as required by Supervision. Overtime as needed.

Requirements

High School Diploma or equivalent required.
Must be able to lift 50 pounds to chest height on an as needed basis.
Must be able to perform assigned tasks for antineoplastic products, including wearing a respirator. This includes initial and ongoing certification.

Nice To Haves

Mechanical and/or microbiology experience preferred.

Responsibilities

Perform high level - Clean Room activities while gowned per site SOP.
Loading, unloading, cleaning, sanitization, and preparation of lyophilizers.
Perform assigned tasks for antineoplastic products, including wearing a respirator (initial and ongoing certification required).
Initiating, monitoring, and troubleshooting lyophilization cycles.
Daily and weekly cleaning requirements.
Ensure all batch documentation is completed properly per cGMPs.
Adhere to SOPs, cGMPs, and Safety Requirements.
Operate and maintain Line 10 per SOP and regulatory requirements, including set-up, changeover, adjustments, and minor repairs to capping and vial wash machines.
Strictly adhere to Aseptic Technique Requirements and proper aseptic technique.
Work closely with maintenance to quickly resolve mechanical issues.
Assume other duties and responsibilities as required by Supervision.
Overtime as needed.