Lyophilization Operator - 2nd Shift

Fresenius Kabi•Grand Island, NY

9d•Onsite

About The Position

The Lyophilization Operator is responsible for overall lyophilization activities, including performing high-level clean room activities while gowned per site SOP. This role involves loading, unloading, cleaning, sanitization, and preparation of lyophilizers. The operator must be able to perform assigned tasks for antineoplastic products, which includes wearing a respirator and obtaining initial and ongoing certification. Responsibilities also include initiating, monitoring, and troubleshooting lyophilization cycles, performing daily and weekly cleaning, and ensuring all batch documentation is completed properly per cGMPs. The operator must adhere to SOPs, cGMPs, and Safety Requirements, and operate and maintain Line 10 per SOP and regulatory requirements, including set-up, changeover, adjustments, and minor repairs to capping and vial wash machines. Strict adherence to Aseptic Technique Requirements is essential. The role involves working closely with maintenance to resolve mechanical issues and performing other duties as required by supervision, including 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.

Nice To Haves

Mechanical and/or microbiology experience preferred.

Responsibilities

Responsible for overall lyophilization activities.
Perform high level - Clean Room activities while gowned per site SOP.
Responsible for 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.
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.