Lyophilization Operator - 2nd Shift

Fresenius; Grand Island (NE); On-site; USD 30,000 - 31,000; Full time

Job summary

Fresenius Kabi in Grand Island, NE is seeking a dedicated technician to oversee lyophilization activities on the 2nd shift. You will perform high-level Clean Room tasks while gowned per site SOP, loading, unloading, cleaning, sanitization, and preparation of lyophilizers, ensuring cGMP compliance.

The role requires ability to lift up to 50 pounds, operate line 10 equipment, and participate in aseptic processing, cycle initiation and troubleshooting, with emphasis on safety and documentation.

Qualifications

• 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.

Responsibilities

• Oversee lyophilization activities and related clean room tasks.
• Load, unload, clean, sanitize, and prepare lyophilizers.
• Initiate, monitor, and troubleshoot lyophilization cycles.
• Ensure batch documentation is completed per cGMPs.

Skills

Lyophilization operations

Clean Room procedures

Safety compliance

Education

High School Diploma

Tools

Capping equipment

Vial wash machine

Job description

Job Summary

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.

Responsibilities

• 2nd Shift is 2:00 PM to 10:30 PM, Monday through Friday

• Hourly Range: $21.50 – 22.50/hour
• Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

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.
• Must be able to lift 50 pounds to chest height on an as needed basis.
• 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
• Mechanical and/or microbiology experience preferred.
• Must be able to lift 50 pounds to chest height on an as needed basis.

Additional Information

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

Please note that joining our team does not create a guaranteed or permanentemployment arrangement. All employment is at‑will, meaning both the employeeand 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 applicantswill receive consideration for employment without regard to race, color, religion, sex, national origin,citizenship, immigration status, disabilities, or protected veteran status.