Engineer

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

Company:
Orca Bio

Compensation:
$85,000 - $105,000 a year

Location:
United States, Sacramento, CA

Employment type:
Regular, Full-Time Employee

Work Arrangement:
On-site

Short Summary:
Orca Bio is a commercial-stage biotechnology company focused on developing next-generation cell therapies to improve survival rates for patients with blood cancer. The Engineer I, MSAT role involves improving the efficiency and safety of the drug product manufacturing process.

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

Requirement:
- 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

Benefits:
- Competitive medical, dental, and vision benefits
- PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits
- Pre-IPO equity and annual bonus eligibility
- Subsidized daily lunches and snacks at on-site locations