Manufacturing Sciences & Technology (MSAT) Process Engineer - Night Shift

Orca Bio • Sacramento, CA

1d • $85,000 - $105,000 • Onsite

About The Position

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 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.

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.

We are multiple positions across the following schedules:

Night Shift:
• 6:00pm to 6:30am or
• 6:30pm to 7:00am

Work Week Schedule:
• Sunday, Monday, Tuesday + every other Wednesday or
• Thursday, Friday, Saturday + every other Wednesday

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
• 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
• 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

Benefits

• You will also be eligible to receive pre-IPO equity, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits.
• Other perks include subsidized daily lunches and snacks at our on-site locations.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level