Lyophilization Operator I

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.

Job Responsibilities:

• Must be able to perform high level - Clean Room activities while gowned per site SOP. This includes initial and ongoing certification.
• Must be able to perform assigned tasks for antineoplastic products, including wearing a respirator. This includes initial and ongoing certification.
• Responsible for loading, unloading, cleaning, sanitization, and preparation of lyophilizers.
• 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.
• 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.
• Responsible for operating product code specific Terminal Sterilization cycles.
• All employees are responsible for ensuring the compliance to company documents, programs and activities related to Health, Safety, Environment, Energy and Quality Management System as per your roles and responsibilities

Job Requirements:

• High school Diploma or GED equivalent
• Minimum of one year experience working a mechanical and/or production environment strongly preferred.
• Aseptic environment and/or regulated industry experience preferred.
• Must be able to lift 50 pounds to chest height on an as needed basis.

The Company's primary business language is English. The successful candidate must be able to effectively speak, read, write, and understand English to perform the essential functions of the position, including independently understanding policies, procedures, training materials, and workplace communications written in English due to our heavily regulated work environment.

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability,401K with company contribution, andwellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is atwill, meaning both the employee and Fresenius Kabi have the right to end the employment relationship at any time, in accordance with applicable federal and state laws.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.