Formulation & Preparation Operator

The Formulation & Preparation Operator supports aseptic filling operations by staging and delivering components, conducting in-process testing, weighing materials, formulation of product, and conducting in-process testing, filtration, cleaning and sanitization, sterilization of equipment, batch reconciliation, compliant gowning, setup and operation of parts washer, autoclaves, and tank cleaning in conformance with current Good Manufacturing Practices and Good Documentation Practices (cGMP/GDP) standards.

Requirements

• Understand and follow current Good Manufacturing Practices (GMP)
• Understand and follow current Good Documentation Practices (GDP)
• Maintain organization at all times within the classified areas to ensure equipment segregation, readiness and to prevent any contamination or rejection of batches.
• Perform routine cleanup, line clearances, and sanitizations as assigned by area supervision to maintain cGMP compliance within the Cleanroom work areas.
• May be required to cross train as a support operator to assist additional manufacturing areas.
• Assist in the training and development of other team members
• Must be able to understand, speak, read and write English in order to comply with necessary SOP’s, job-specific training materials, GMP’s, and other manuals.
• Basic Computer skills in Microsoft Word, Excel, and Outlook and the ability to use enterprise software (examples include: Veeva, D365, Blue Mountain, etc.)
• Must have the ability to work effectively in a ”hands on environment” capable of troubleshooting complex equipment and systems
• Competency in operation of multiple types of equipment related to the manufacturing operations as well as hand operated equipment including, but not limited to, such things as calipers, scales, gauges, and other measuring devices.