Upstream, Manufacturing Engineer
Goodwin Biotech - Plantation, FL

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Quality Assurance
  • Work Days: M-F Full Time
    Reports to:


    Re

    ports to: Manager, Upstream Manufacturing Scope of Function: Responsible for cGMP Upstream Manufacturing Operations including cell culture and bioreactor processing. Specific Duties: 1. Coordinate Upstream Manufacturing activities to ensure projects are performed in accordance with cGMP guidelines and are completed in a manner that meets or exceeds client’s expectations 2. Interact with other department heads to resolve process and operations issues promptly 3. Write, review and/or approve written procedures, SOP’s, validation reports, design inputs, exception documents and other cGMP documents
    4. Review and summarize manufacturing data in reports. Prepare change control and deviation documentation working with QA
    5. Interact with Facility to ensure manufacturing equipment and instruments are in cGMP compliance and coordinate appropriate repairs and maintenance
    6. Help to lead technology transfer internally and externally, provide technical support for large-scale non-GMP and cGMP plant operations
    7. Help ensure that staff members are properly trained for their job functions and that the training is documented in cGMP training records

    Education Required:
    BS or MS in engineering or biological science or related field.

    Experience Required:
    Minimum of 5 years experience in cGMP biologics manufacturing. A detailed working knowledge of cell culture and bioreactor production. Phase I-III clinical manufacturing and/or commercial manufacturing. Knowledge of biologics manufacturing, validation protocols, identification and specification of equipment, IQ-OQ, and operations.

    Interacts With:
    Upstream and Downstream Manufacturing, Cell Culture and Process Development. In addition, interacts with Facilities group within the Manufacturing Operations as well as with Project Management, Materials Management, Quality Control and Quality Assurance groups.
    Goodwin Biotech - 14 months ago - save job