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

Orca Bio•Sacramento, CA

6d•$85,000 - $105,000•Onsite

About The Position

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 have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) 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. 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.

Requirements

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
Strong communication and problem-solving skills, with a desire to improve upon established processes

Nice To Haves

Experience in biotechnology and cell therapy manufacturing preferred

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