MSAT Process Engineer — Biotech Cell Therapy, GMP, Equity

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, vision benefits

PTO

401(k) plan

Life and AD&D coverage

Parental leave

Job summary

Orca Bio is expanding East Coast manufacturing operations to ensure reliable delivery of high-precision cell therapies. The MSAT Process Engineer will oversee life cycle management for clinical and commercial products, including process monitoring, improvements, validation, and CAPA investigations.

The role emphasizes root-cause analysis, change controls, and troubleshooting in a GMP setting, with shifts on 2nd and 3rd, and opportunities for pre-IPO equity and annual bonus.

Qualifications

• B.S. in Engineering required or similar field.
• 3+ years of experience with manufacturing processes and equipment in related fields (biologics, fill/finish, or drug substance).
• Experience in regulated GMP manufacturing operations; biotech/cell therapy preferred.

Responsibilities

• Monitor existing products and processes.
• Generate metrics and reports for process verification.
• Support improvements and changes including batch records.
• Investigate events and implement corrective actions.
• Provide troubleshooting for manufacturing events and equipment.
• Write validation protocols and life-cycle documents.

Skills

Process monitoring

Root cause analysis

Troubleshooting

Change controls

Education

B.S. in Engineering

Tools

Electronic batch records

Job description

Orca Bio is expanding East Coast manufacturing operations to ensure reliable delivery of high-precision cell therapies. The MSAT Process Engineer will oversee life cycle management for clinical and commercial products, including process monitoring, improvements, validation, and CAPA investigations.

The role emphasizes root-cause analysis, change controls, and troubleshooting in a GMP setting, with shifts on 2nd and 3rd, and opportunities for pre-IPO equity and annual bonus.