Lyophilization Operator - 3rd Shift

Fresenius Kabi USA, LLC; Grandyle Village (NY); On-site; USD 29,000 - 32,000; Full time

Job summary

Fresenius Kabi USA, LLC is seeking a Lyophilization Technician responsible for overall lyophilization activities in a clean room environment, loading/unloading, sanitization, and preparation of lyophilizers.

The role requires handling antineoplastic products with respirator certification, 3rd shift 10:00 PM–6:30 AM, and adherence to cGMPs and SOPs; lifting up to 50 pounds; contributes to batch documentation and operating Line 10 equipment.

Qualifications

• High School Diploma or equivalent required.
• Mechanical and/or microbiology experience preferred.

Responsibilities

• Load, unload, clean, sanitize, and prepare lyophilizers.
• Initiate, monitor, and troubleshoot lyophilization cycles.
• Perform daily and weekly cleaning.
• Ensure batch documentation is completed per cGMPs.
• Adhere to SOPs and safety requirements.
• Operate Line 10 per SOP and perform minor repairs to capping and vial wash machines.
• Maintain aseptic technique.
• Collaborate with maintenance to resolve issues.
• Overtime as needed.
• 3rd Shift is 10:00 PM to 6:30 AM, Monday through Friday nights.

Skills

Aseptic technique

SOP compliance

Safety awareness

Education

High School Diploma or equivalent

Tools

Lyophilizers

Capping machines

Vial wash machines

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.

Must be able to perform assigned tasks for antineoplastic products, including wearing a respirator. This includes initial and ongoing certification.

Responsibilities

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

• Hourly Range: $21.50 - 23.50/hour


• Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities.

• 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 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.