Engineer, Manufacturing Sciences & Technology (MSAT) (3rd Shift)

Job description

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 commercial-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 cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. We operate a dedicated clinical manufacturing facility in Sacramento, CA (3400 Business Drive), which has historically served as the foundation for producing our high-precision cell therapy products. This site plays a critical role in advancing our clinical pipeline and ensuring the consistent, reliable supply of therapies for patients participating in our trials. Engineer I, MSAT, works to improve the efficiency and safety of the drug product manufacturing process. This role is responsible for life cycle management of commercial products including process monitoring and troubleshooting, implementation and validation of process improvements and changes, and supporting investigations and corrective/preventive actions. The Engineer I works on well-defined problems with clear scope and known troubleshooting paths, typically under guidance from more senior engineers or a manager. ### Physical Demands - Production Associates: 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. - 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. ### Work Conditions - Must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs. - Must be comfortable regularly participating in video-based meetings. - May be required to work scheduled overtime, weekends, or holidays based on business needs. ### Essential Duties & Key Responsibilities: - Performs ongoing monitoring of existing commercial products and processes - Generates metrics and reports for process monitoring and continuous process verification - Supports 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 - Supports the authoring, execution and ownership of change controls, CAPAs, technical protocols, reports and activities to support improvements - Ensures proper execution of validation protocols and testing in line with required life cycle management activities - Troubleshoots issues within a defined scope, seeking guidance from senior team members as needed - Supports validation activities, technical studies, and process improvement projects under the direction of senior engineers - Learns from experienced engineers and contributes to collaborative problem-solving efforts ### Minimum Qualifications: - B.S. in Engineering or similar fields, or equivalent combination of education and directly relevant experience - 0-2 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 **3rd Shift:** • Monday - Friday, 11:00pm - 7:00am