Lyophilization Operator I

Fresenius SE & Co. KGaA; Melrose Park (IL); On-site; USD 2,586,719 - 3,684,115; Full time

Benefits offered by this job

401(k) plan with company contribution

Paid vacation

Medical, dental and vision coverage

Job summary

Fresenius SE & Co. KGaA in Melrose Park, Illinois, is seeking a candidate for lyophilization responsibilities. The role includes executing the lyophilization cycle and ensuring compliance with cGMP regulations.

Qualified candidates should have a high school diploma and at least one year of experience in a mechanical or production environment. The position offers an hourly rate of $22.76, plus a robust benefits package including health coverage and a 401(k) plan with company contributions.

Qualifications

• Minimum of one year experience in a mechanical or production environment preferred.
• Experience in an aseptic environment and/or regulated industry is preferred.
• Ability to lift 50 pounds to chest height when needed.

Responsibilities

• Initiate, monitor, and execute lyophilization and Terminal Sterilization cycles.
• Perform clean room activities and maintain certification.
• Ensure batch documentation adherence to cGMPs.

Skills

Mechanical skills

Aseptic technique

Clean Room activities

Education

High school diploma or GED equivalent

Job description

Job Summary

Starting Hourly Rate: $22.76

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

Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage.

Responsibilities

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.

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, and wellness program.

Please note that joining our team does not create a guaranteed or permanent employment arrangement. All employment is at‑will, 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.