Lyophilization Operator I (12-Hour Overnight Shift)

Fresenius Kabi; Melrose (MA); On-site; USD 31,000 - 34,000; Full time

Benefits offered by this job

401(k) with company contributions

Paid vacation, holidays, personal days

Employee assistance program

Health benefits: medical, dental, and视

Vision coverage

Job summary

Fresenius Kabi in Melrose, MA is seeking a production operator to initiate, monitor and execute lyophilization and terminal sterilization cycles. You will work in a clean room environment, handling equipment and complying with cGMPs.

Strong English reading/writing skills are required to follow policies and training materials. Responsibilities include loading/unloading, cleaning, troubleshooting, and ensuring accurate batch documentation.

Qualifications

• Aseptic technique and clean room experience preferred.
• Experience in mechanical/production environment encouraged.
• Ability to read and understand English documentation.

Responsibilities

• Initiate, monitor and execute lyophilization cycles for all products.
• Initiate, monitor and execute terminal sterilization cycles per SOPs.
• Prepare equipment, operate controls, troubleshoot, and unload products.
• Maintain cGMP compliance and complete batch documentation.

Skills

Aseptic technique

Mechanical production

English literacy

Education

High School Diploma or GED

Job description

Job Summary

Starting Hourly Rate: $22.76 per hour

Overnight Shift Differential: $1.75 per hour

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.

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.

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 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.