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About the Role

This role is responsible for overall lyophilization activities, including clean room operations, loading/unloading, cleaning, sanitization, and preparation of lyophilizers. The position also involves working with antineoplastic products, requiring respirator use and certification, and ensuring proper documentation completion per cGMPs.

Responsibilities

• Perform high level - Clean Room activities while gowned per site SOP.
• Load, unload, clean, sanitize, and prepare lyophilizers.
• Perform assigned tasks for antineoplastic products, including wearing a respirator and obtaining certification.
• Initiate, monitor, and troubleshoot lyophilization cycles.
• Complete 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.
• Work overtime as needed.

Requirements

• High School Diploma or equivalent required.
• Mechanical and/or microbiology experience preferred.
• Must be able to lift 50 pounds to chest height on an as needed basis.
• Must be able to effectively speak, read, write, and understand English to perform the essential functions of the position.

Work Type

• 3rd Shift is 10:00 PM to 6:30 AM, Monday through Friday nights
• Overtime as needed

Education Level

• High School Diploma or equivalent required

Salary/Compensations

• $21.50 – 23.50/hour

Benefits

• 401(k) plan with company contributions
• Paid vacation, holiday and personal days
• Employee assistance program
• Health benefits to include medical, prescription drug, dental and vision coverage
• Medical, dental and vision coverage
• Life insurance
• Disability
• 401K with company contribution
• Wellness program

About the Company

• Fresenius Kabi is an Equal Opportunity/Affirmative Action employer.

Equal Opportunity

• 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.