MSAT Process Engineer, Cell Therapy (3rd Shift)

Orca-Bio; California (MO); On-site; USD 85,000 - 105,000; Full time

Benefits offered by this job

Pre-IPO equity

Annual bonus

Medical insurance

Dental insurance

Vision insurance

PTO

401(k)

Life insurance

AD&D

Parental leave

Lunches on-site

Job summary

Orca Bio in Sacramento, CA, is hiring Engineer I, MSAT, to improve efficiency and safety of our commercial drug product manufacturing. You will manage life cycle of products, monitor processes, implement improvements, and support investigations under supervision.

The role emphasizes troubleshooting, CAPAs, change controls, validation protocols, and close collaboration with senior engineers. Requires a BS in Engineering and 0–2 years GMP experience; on 3rd shift, salary $85,000–$105,000 with

Qualifications

• BS in Engineering or related field 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/finish, 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

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

Skills

Strong communication

Problem solving

Education

BS in Engineering or related field

Job description

Orca Bio in Sacramento, CA, is hiring Engineer I, MSAT, to improve efficiency and safety of our commercial drug product manufacturing. You will manage life cycle of products, monitor processes, implement improvements, and support investigations under supervision.

The role emphasizes troubleshooting, CAPAs, change controls, validation protocols, and close collaboration with senior engineers. Requires a BS in Engineering and 0–2 years GMP experience; on 3rd shift, salary $85,000–$105,000 with