Production Technician I (12-Hour Overnight Shift)
Fresenius Kabi USA
Summary
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.
Job description
Job Summary
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
Benefits
- 401(k) With Company Contributions
- Paid Vacation
- Paid Holidays
- Personal Days
- Employee Assistance Program
- Medical Insurance
- Prescription Drug Coverage
- Dental Insurance
- Vision Coverage
- Life Insurance
- Disability Insurance
- Wellness Program
Company overview
Fresenius Kabi USA is a leading global healthcare company and a subsidiary of Fresenius Kabi AG, specializing in pharmaceutical manufacturing and medical technologies. Headquartered in Lake Zurich, Illinois, the company operates as a comprehensive provider of essential medicines and technologies for critically and chronically ill patients. With over 43,000 employees globally and a presence in more than 100 countries, Fresenius Kabi USA focuses on four complementary business areas: Biopharma (biosimilars for autoimmune diseases and oncology), Pharma (IV drugs and infusion therapy), Medical Nutrition, and MedTech. The company's extensive portfolio includes injectable drugs, delivery systems, advanced transfusion medicine, cell therapy technologies, clinical nutrition products, and infusion devices. Serving hospitals, long-term care facilities, alternate care sites, and clinics, Fresenius Kabi USA is committed to providing high-quality, lifesaving medicines and technologies while driving healthcare transformation through innovation and patient-centric solutions.