Manufacturing Sciences & Technology (MSAT) Process Engineer, 2nd/3rd Shifts

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 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.
Summary of Role: 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 commercial products including process monitoring and troubleshooting, implementation and validation of process improvements and changes, and supporting investigations and corrective/preventive actions.
2nd shift: working on-site Monday through Friday, from 3pm to 11:30pm.3rd shift: working on-site Monday through Thursday, from 9pm to 7:30am.

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.

Responsibilities

• Performs ongoing monitoring of existing commercial 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 

Education & Experience Requirements

• 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 

Who we are
We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.
We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.
We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.
We maintain a start-up culture of camaraderie and leadership by example, regardless of title.
We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger