Production Technician I (12-Hour Overnight Shift)

Fresenius Kabi USA; Melrose Park (IL); On-site; USD 28,000 - 39,000; Full time

Benefits offered by this job

401(k) plan with company contributions

Paid vacation, holidays & personaldays

Employee assistance program

Health, dental and vision coverage

Job summary

Fresenius Kabi USA in Melrose Park, IL is seeking an aseptic manufacturing technician to assemble, operate, and monitor state-of-the-art equipment in a GMP environment. The role requires adherence to SOPs, strong aseptic techniques, and English proficiency.

The position features 12-hour shifts on a 2-2-3 schedule and a competitive benefits package. Responsibilities include operating HMI applications, loading materials, performing basic setup and troubleshooting, and collaborating with MQA,

Qualifications

• Minimum of a High School Diploma, GED, or equivalent with one year of experience in a relevant work environment.
• Able to work 12hr shifts on a 2-2-3 schedule.
• Able to stand on concrete floors for an extended period.
• Able to lift up to 35 pounds and move heavy equipment as needed.
• Able to work with hazardous materials including antineoplastic products.
• Must understand, speak, and write English to comply with SOPs, GMPs and training materials.

Responsibilities

• Assemble, operate and monitor aseptic equipment per SOP and GMP.
• Operate advanced HMI applications.
• Load components and materials into machines and perform basic setup/troubleshooting.
• Maintain aseptic manufacturing principles and gown qualification when required.
• Perform microbiological monitoring within filling, ALUS, and capping areas.
• Collaborate with MQA, Maintenance, Metrology, Engineering, Validation, Tech Transfer and Microbiology.

Skills

Aseptic techniques

HMI operation

English language

GMP compliance

Education

High School Diploma, GED, or equivalent

Job description

Job Summary

Hourly Payrate: $24.27 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

The technician will be responsible for assembling, operating, and monitoring state-of-the-art, aseptic equipment following applicable Standard Operating Procedures and current Good Manufacturing Practices. Must be knowledgeable of and practice good aseptic techniques to minimize the potential for product contamination as well as understand advanced computerized systems through HMI.

Technical Responsibilities:

• Ability to operate advanced HMI applications.
• Perform basic level machine operation, set-up and troubleshooting of all state-of-the-art equipment in their area (may include Vial Washer, Depyrogenation Tunnel, Filling Machine, Isolator, Stopper Loading Systems, Capping Machine, Glove Tester, Automatic Loading & Unloading System (ALUS), Lyophilizers, Parts Washers, Component Sterilizers, Stopper Cans, Filter Integrity Tester, Vaporized Hydrogen Peroxide Transfer Hatch) to meet process parameters
• Load Parts Washer, Component Sterilizer, Vial Washer, Filling Machine and Capping Machine with raw materials and format parts
• Practices and understands aseptic manufacturing principles Maintains gown qualification if required by their area
• Perform microbiological monitoring within the Filling Machine, ALUS, and Capping Machine
• Assist other departments including MQA, Maintenance, Metrology, Engineering, Validation, Tech Transfer and Microbiology, with tasks on the equipment in their area

General Responsibilities:

• Clean and sanitize equipment and Production areas per SOP
• Transfer raw materials, operating supplies, and finished product in and out of the manufacturing areas
• Multi-task and learn multiple manufacturing areas
• Train and comply with current SOPs and GMPs
• Documents work accurately and timely
• Understand the process flow and step by step requirements for manufacturing
• Work in a time efficient manner while maintaining adherence to all applicable SOPs
• Concise communication with co-workers and managers to promote a teamwork atmosphere
• Perform other duties as directed
• All employees are responsible for ensuring compliance with company documents, programs, and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems as per your roles and responsibilities

Requirements:

• Have a minimum of a High School Diploma, GED, or equivalent education with one year of experience in a relevant work environment
• Able to work 12hr shifts on a 2-2-3 schedule
• Able to stand on concrete floors for an extended period of time
• Able to lift up to 35 pounds by bending and lifting
• Able to move heavy equipment and components as needed
• Able to work with hazardous materials including antineoplastic products and raw materials that could lead to serious illness/injury
• Able to wear required personal protective equipment (eye protection, safety shoes, gown, gloves)
• Must be able to understand, speak, and write English in order to comply with necessary SOPs, SPECs, Job-specific training materials, GMPs, and other manuals

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.