In this role, you will operate a variety of processing and packaging equipment to manufacture cell culture media in accordance with current Good Manufacturing Practices. This role resides in our Liquid Filtration department, which is primarily responsible for setup and operation of filling equipment for routine aseptic processes, performance of filling tasks with proper aseptic technique to prevent negative Safety and Quality product impact and monitoring/maintenance of production equipment to ensure continued operation. Duties of this role are primarily completed in a controlled clean room environment. Individuals in this role are required to maintain gowning qualification in order to operate in clean room environment. This role requires: strong application of aseptic technique, ability to complete production documentation according to cGMP guidelines, ability to operate in gowning equipment for long periods of time and successful annual completion of media fill validation to maintain aseptic filling qualification.
Scope of Role:
In the Operator II role you will be expected to complete moderately complex tasks and routine assignments through application of technical and procedural knowledge, including:
· Following SOPs to perform moderately complex tasks (sometimes technical in nature)
· Using experience and logic to solve routine to moderately complex problems within process guidelines
· Adjusting to changes in work volume
· Escalating all deviations to a Lead/Supervisor
· Interacting within a team
In this role you may complete some or all of the following duties:
· Sets up and operates filling equipment for routine aseptic processes
· Performs filling tasks with proper aseptic technique to prevent negative Safety and Quality product impact
· Operate processing and packaging equipment to manufacture cell culture media. Equipment includes mixers, mills, blenders, pumps, filtration systems, and packaging equipment.
· Weigh, measure and check raw materials with assistance of computer interface to assure batches manufactured contain proper materials and quantities.
· Calibrate/operate semi-automated and automated manufacturing equipment.
· Perform in-process sampling and testing to assure batches meet specification.
· Follow all safe practices and SOP’s.
· Complete and maintain Quality Records in compliance with regulatory requirements, GMP’s and standard operating procedures.
· Maintain equipment and rooms in proper operating condition and proper cleanliness requirements.
· Perform activities in a controlled environment up to and including classified clean room conditions.
· May be required to perform other related duties as required and/or assigned.
Requires a high school diploma or equivalent.
General understanding of machinery and mechanics is required. Strong attention to detail required.
Experience working with a strong focus on quality of product required. Prior experience in a GMP manufacturing environment is preferred. Knowledge of computer applications and current software is desirable.
Works in a controlled manufacturing environment; is required to lift up to 45 lbs. and may be required to stand for long periods of time while performing duties. Must be able to work safely with materials and equipment. Must be able to work overtime and flexible shifts. Various levels of gowning are required.