MSAT Process Engineer: Biologics Cell Therapy (2nd/3rd)

Orca Bio; Princeton (NJ); On-site; USD 80,000 - 100,000; Full time

Benefits offered by this job

Pre-IPO equity

Annual bonus

Medical, dental, and vision benefits

PTO

401(k)

Life insurance

AD&D

Parental leave

Job summary

Orca Bio is building manufacturing operations on the East Coast to deliver high-precision cell therapies. We are seeking a MSAT Process Engineer to oversee life cycle management of clinical and commercial products, monitor process performance, and drive improvements with robust validation and change control.

The role focuses on process monitoring, troubleshooting, and investigations in a GMP environment. Second and third shifts include evening and overnight hours to support operations.

Qualifications

• Requires B.S. in Engineering or related field.
• 3+ years in manufacturing processes/equipment in biologics, pharma fill and finish, or drug substances.
• Experience in GMP manufacturing operations in regulated environments.
• Experience in biotechnology/cell therapy manufacturing preferred.
• Strong communication and problem-solving skills; ability to improve processes.
• Willingness to work outside standard business hours when needed.

Responsibilities

• Monitor existing products and processes.
• Generate metrics for process monitoring and verification.
• Support process improvements and changes including electronic batch records.
• Investigate process events and implement corrective/preventive actions.
• Troubleshoot manufacturing events, equipment performance, and material issues.
• Perform root cause analysis to identify corrective actions.
• Author and manage change controls, protocols, and validation activities.

Skills

Manufacturing experience

Communication

Problem solving

Flexibility

Education

B.S. in Engineering or related field

Job description

Orca Bio is building manufacturing operations on the East Coast to deliver high-precision cell therapies. We are seeking a MSAT Process Engineer to oversee life cycle management of clinical and commercial products, monitor process performance, and drive improvements with robust validation and change control.

The role focuses on process monitoring, troubleshooting, and investigations in a GMP environment. Second and third shifts include evening and overnight hours to support operations.