MSAT Process Engineer – 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 benefits

Dental benefits

Vision benefits

PTO

401(k)

Life insurance

AD&D

Parental leave

Job summary

Orca Bio is seeking a MSAT Process Engineer to improve the efficiency and safety of the drug product manufacturing process. This role supports lifecycle management of clinical and commercial products, including process monitoring, troubleshooting, and implementing improvements.

You will also write validation protocols, manage change controls, and support investigations and CAPAs. The position requires a B.S. in Engineering with GMP experience and strong cross‑functional collaboration.

Qualifications

• B.S. in Engineering or similar field.
• 3+ years of manufacturing processes and equipment experience.
• Experience in GMP regulated manufacturing.
• Biotech/cell therapy manufacturing preferred.
• Strong communication and problem solving skills.
• Willing to work outside standard hours when needed.

Responsibilities

• Monitor existing products and processes.
• Generate metrics and reports for process verification.
• Support process improvements and changes including EBR creation.
• Investigate process events and implement CAPAs.
• Provide troubleshooting for manufacturing events and equipment performance.
• Write validation protocols and lifecycle documentation.

Skills

Communication

Problem solving

Flexibility

Attention to detail

Continuous improvement

Education

B.S. in Engineering

Tools

Electronic Batch Record

Job description

Orca Bio is seeking a MSAT Process Engineer to improve the efficiency and safety of the drug product manufacturing process. This role supports lifecycle management of clinical and commercial products, including process monitoring, troubleshooting, and implementing improvements.

You will also write validation protocols, manage change controls, and support investigations and CAPAs. The position requires a B.S. in Engineering with GMP experience and strong cross‑functional collaboration.