Position Purpose : |
Filling of insulin and media preparations under aseptic conditions and operation of inspection equipment to achieve production goals.
- Work in a safe and environmentally responsible manner
- Operating, monitoring and controlling equipment, systems and processes associated with the Vial/Cartridge filling and inspection lines
- Achieving production goals
- Maintaining aseptic areas and performing sanitizations and environmental monitoring
- Actively participate in and support event response
- Reviewing and authoring SOP's and other documents as required
- Assist during equipment maintenance including restoration of lost function, predictive and preventative maintenance
- Train fellow employees in areas of expertise, and aggressively learn systems and equipment outside of own expertise
- Recording/reviewing of production data in BPR's and associated forms
- Other accountabilities as assigned
Required Education :
- High school graduate or equivalent
- AAS degree in related field or BioWork graduate
- Minimum of 1 year experience in a manufacturing industry
Technical/Process/Functional Knowledge :
- FDA regulated and Aseptic processing experience
Ability to read, write and understand complicated product documentation and standard operating procedures with attention to detail and computer literacy.
Proven expertise in planning/organizing, managing execution, checking results, and revising the work plan in accordance with the daily work plan.
Demonstrate the ability to perform basic material handling tasks and safely and effectively use material handling equipment.
Physical and other Requirements:
- Ability to lift up to 60 lbs. with assistance
- Ability to work in confined spaces and near operating equipment
- Ability to attain clean room gowning certification and work with hazardous materials including sanitants
- Frequent bending, stooping, and prolonged working overhead
- Ability to work hours necessary to support production
- Ability to stand on feet up to 12 hours or longer, day or night
- Corrected vision to 20/30
Requisition ID: 58849BR
Job Category: manufacturing