Aseptic Control Operator II

Job Summary Aseptic Control Operators are responsible for the cleaning, changeover, setup, startup, operation, and breakdown of production lines. Additionally, they may be assigned tasks related to the general upkeep of the area, such as unloading ovens and sterilizers, performing routine cleaning, and performing minor maintenance. All of these activities are governed by strict procedures and regulations and require a high degree of training. Therefore, Aseptic Control Operators must complete all required training, and follow all applicable Standard Operating Procedures, Batch Records, and Protocols, and must be familiar with current Good Manufacturing Practices. Responsibilities PRINCIPAL ACTIVITES PERFORMED BY THE INCUMBENT Cleaning, changeover, setup, startup, operation, and breakdown of production lines. Use of proper aseptic technique at all times while working in aseptic areas. Documenting work accurately and in a timely manner Minor maintenance and preventative maintenance of production lines. Routine cleaning of production lines and other clean rooms. Unloading sterilizers and ovens. Adheres to SOP's, cGMP's and Safety Requirements. Performs "shadow" training of new Aseptic Control Operators. Obtain DEA Clearance for Controlled Substance Vault access Performs other duties as assigned by management. All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities MANAGEMENT SCOPE Manages, mentors and coaches 4 or more employees. Has hiring, firing and performance decision power Manages, mentors and coaches less than 3 employees. Has hiring, firing and performance decision power Manages, mentors and coaches other employees. Does NOT have hiring, firing and performance decision power Does NOT manage other employees. Does NOT have hiring, firing and performance decision power REQUIREMENTS High school diploma or equivalency required. Must meet internal job qualification standards and must be a qualified trainer to Aseptic Control Operator I Mechanical aptitude required. Must be able to lift 50 pounds with assistance Must be able to wear personal protective equipment Must work overtime as necessary to support production (weekday and weekends). 1+ year of experience MINIMUM LEVEL OF EDUCATION REQUIRED FOR POSITION High School Diploma/GED/No Degree NUMBER OF YEARS OF JOB EXPERIENCE REQUIRED FOR POSITION Minimum of 1 year 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, citizenship, immigration status, disabilities, or protected veteran status.