Job Description
Job Summary
Responsible for assembling, operating and monitoring a state of the art, aseptic filling machine in accordance with applicable Standard Operating Procedures and current Good Manufacturing Practices. Must be knowledgeable of and practice good aseptic technique to minimize potential for product contamination as well as understand advanced computerized systems through HMI.
Responsibilities
PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT
Ability to operate advanced HMI applications.
Set-up, fine-tune, operate, and troubleshoot state of the art filling machine with Isolator to meet process parameters.
Maintains equipment, change parts, and supplies inventories by checking stock to determine inventory level; anticipating needed equipment, parts, and supplies.
Comply with current SOP's and GMPs.
Maintains and understands aseptic manufacturing principles related to isolator technology.
Documents work accurately and timely.
Technical comprehension of mechanical functions and controls for filling equipment and isolator.
Works in a time efficient manner while maintaining adherence to all applicable SOP's .
Adept at problem solving. Specifically to identifying problem, developing solution, and execution of remedy and elevate to management if necessary.
Concise communication with co-workers and managers to promote teamwork atmosphere.
The ability to multi-task.
Understand the process flow and step by step requirements for manufacturing.
Reconciles components and product.
Perform other duties as directed.
REQUIREMENTS
Associate Degree plus 3-5 years of pharmaceutical experience required or BS degree in Engineering or Sciences or 7+ years of pharmaceutical Filling/Isolator experience
Advanced HMI aptitude
Experience in reading CAD mechanical and electrical drawings preferred
Experience in FDA regulated work environment
Can lift up to 30lbs
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 match, and wellness program.
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, disabilities, or protected veteran status.