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Orca Bio

Posted 2 months ago

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Manufacturing Sciences and Technology (MSAT) Process Engineer (2nd/3rd Shift)

Princeton, NJOn-site

AI Summary

Process Engineer supporting life cycle management of clinical and commercial cell therapy products, monitoring processes, implementing improvements, and performing root-cause troubleshooting in a regulated manufacturing environment.

About this role

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a late-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks. With our purified, high-precision investigational cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives.
We are establishing manufacturing operations on the East Coast to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies.
The MSAT Process Engineer works to improve the efficiency and safety of the drug product manufacturing process. This role is responsible for life cycle management of clinical and commercial products including process monitoring and troubleshooting, implementation and validation of process improvements and changes, and supporting investigations and corrective/preventive actions.

Essential Duties & Key Responsibilities:

  • Performs ongoing monitoring of existing products and processes
  • Generate metrics and reports for process monitoring and continuous process verification
  • Support process improvements and changes including electronic batch record creation and modifications
  • Investigates process events and implements corrective and preventive actions
  • Provides troubleshooting support for manufacturing events, equipment performance and material issues
  • Performs root cause analysis to isolate cause of events and determine appropriate corrective actions
  • Authors, executes and owns change controls, technical protocols, reports and activities to support improvements
  • Writes and ensure proper execution of validation protocols and testing in line with required life cycle management activities

    • Minimum Qualifications:

  • B.S. in Engineering or similar fields
  • 3+ years of experience with manufacturing processes and equipment in related fields: biologics, pharmaceutical fill and finish or drug substance manufacturing, Chemical or food industries
  • Prior experience in regulated, GMP manufacturing operations
  • Experience in biotechnology and cell therapy manufacturing preferred
  • Strong communication and problem solving skills, with a desire to improve upon established processes
  • Flexibility to work outside standard business hours when needed to support site priorities, deadlines, or critical business needs.
    • 2nd Shift:
    • Monday - Friday, 4:00pm - 12:30am
    3rd Shift:
    • Monday - Friday, 12:00am - 8:30am

    Physical Demands

  • Production Associate Roles: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment.
  • Most roles must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed.

    • Skills

    Batch RecordBiologicsCell Therapy ManufacturingCorrective And Preventive Action (CAPA)GMPManufacturing Process MonitoringRoot-cause AnalysisValidation

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