Component Prep Operator I - 3rd Shift
Fresenius Kabi USA
Summary
Responsible for cleaning, visual verification, assembly of filling room set-up equipment, and operation of component sterilizers in Grade C and D clean room environments. Also responsible for the set-up, operation and performance of all vial washers and component sterilizers. Operates all equipment used in these areas efficiently, safely, and consistently.
Job description
Job Summary
Responsible for cleaning, visual verification, assembly of filling room set-up equipment, and operation of component sterilizers in Grade C and D clean room environments. Also responsible for the set-up, operation and performance of all vial washers and component sterilizers. Operates all equipment used in these areas efficiently, safely, and consistently.
Responsibilities
- 3rd Shift is 10:00 PM to 6:30 AM, Monday through Friday nights
- Comprehends basic math, reading and basic mechanical adjustments
- Performs tasks as requested by supervision
- Wears appropriate safety equipment (i.e., safety glasses/shoes)
- Adheres to mid-level gowning requirements for Grade C and D clean room environments
- Follows all required SOPs/GMPs/safety requirements during execution of daily duties
- Responsible for restocking production supplies
- Assures that batch record, cleaning documentation, and logbook entries are accurate and comply to standard operating procedures
- Verifies that sterilization cycle conforms to established acceptance criteria
- Loads applicable sterilizers per validated loading configurations
- Performs cleaning and visual verification of filling room set-up equipment within recommended time requirements
- Performs daily and weekly cleaning/sanitization of the area as specified in the SOP
- Loads glass and plastic vials onto vial washer infeed and monitors performance of washing progress
- Performs changeover of vial washer as required per production schedule
- Accurately separates and labels any waste
Requirements
- High School Diploma or equivalent required
- Previous experience in Pharmaceutical or related-industry experience preferred
- Mechanical aptitude highly preferred
- Good communication and documentation skills required
- Comprehends basic math, reading and basic mechanical adjustments
- Must be able to lift successive vial pans weighing approximately 20 lbs
- Must be able to lift, bend, and reach while palletizing vial pans weighing approximately 20 lbs
- Must be able to pull and push vial racks weighing approximately 1800 lbs using a manual pallet jack
- Must be able to work in slippery wet conditions while operating equipment and performing manual cleaning of equipment
- Must be able to pass Vision 5 visual acuity testing administered by occupational health administrator, pre-employment and annually thereafter
Benefits
- Medical, Dental & Vision
- Life Insurance
- Disability Insurance
- 401(k) with company contribution
- 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.