Posted 22 days ago

Manufacturing Sciences and Technology (MSAT) Process Engineer

Princeton, NJOn-siteFull-time

AI Summary

MSAT Process Engineer supports manufacturing process monitoring, troubleshooting, and process improvements for clinical and commercial cell therapy products, driving continuous process verification and CAPA actions.

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.

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 RecordsBiologics ManufacturingCAPACell Therapy ManufacturingChange Control DocumentationCI/CD (change Controls)CQACQVData TrendingElectronic Batch RecordsGMPInstrumentationManufacturing Equipment TroubleshootingProcess MonitoringProcess ValidationRisk AssessmentRoot-cause AnalysisStatistical Process ControlTechnical ProtocolsValidation Protocols

Manufacturing Sciences and Technology (MSAT) Process Engineer

About this role

Essential Duties & Key Responsibilities:

Minimum Qualifications:

Physical Demands

Skills

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