Engineer, Manufacturing Sciences & Technology (MSAT)
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 Engineer, 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.
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 with data analysis and trending using JMP or other statistical software
- Follow cleanroom protocols, e.g. no cosmetics including make-up, painted nails, jewelry or piercings, and must disclose any shedding skin condition
Nice To Haves
- Experience in biotechnology and cell therapy manufacturing preferred
- Experience with commercial packaging, labeling, and cold chain strongly preferred
- Excellent communication and problem solving skills, with a desire to improve upon established processes
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
- Performs Out of Trend Investigations based on trends from process monitoring
- 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 and owns change controls, technical protocols, reports and activities to support process improvements
- Writes and ensures proper execution of validation protocols and testing in line with required life cycle management activities
- Leads design, project management and execution of MSAT projects, introduction of new materials, and equipment at multiple GMP facilities
- Assess potential impact of supplier changes, material changes, Drug product labels, Drug Product packaging and cold chain transport changes and excursions
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.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
