Night Shift MSAT Process Engineer — Biotech Cell Therapy

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

Benefits offered by this job

Health insurance

Job summary

Orca Bio in Princeton, NJ is seeking a MSAT Process Engineer to improve the efficiency and safety of our drug product manufacturing. This role covers life cycle management for clinical and commercial products, including process monitoring, changes, and investigations.

You will lead validation and change controls, support electronic batch records, and collaborate with manufacturing and quality teams to ensure compliance with GMP standards and on-time delivery of our cell therapy products.

Qualifications

• B.S. in Engineering or related field.
• 3+ years in GMP manufacturing.
• Experience in biotech/cell therapy manufacturing preferred.

Responsibilities

• Monitor existing products and processes.
• Generate metrics and reports for process verification.
• Support process improvements and batch records.
• Investigate events and implement corrective actions.
• Provide troubleshooting for manufacturing issues.
• Perform root cause analyses and corrective actions.
• Lead change controls and validation activities.
• Write validated protocols and testing per lifecycle management.

Skills

GMP manufacturing

Process monitoring

Root cause analysis

Change control

Education

B.S. in Engineering

Job description

Orca Bio in Princeton, NJ is seeking a MSAT Process Engineer to improve the efficiency and safety of our drug product manufacturing. This role covers life cycle management for clinical and commercial products, including process monitoring, changes, and investigations.

You will lead validation and change controls, support electronic batch records, and collaborate with manufacturing and quality teams to ensure compliance with GMP standards and on-time delivery of our cell therapy products.