MSAT Process Engineer - Cell Therapy Ops (3rd Shift)

Orcabiosystems; Princeton (NJ); On-site; USD 90,000 - 125,000; Full time

Benefits offered by this job

Pre-IPO equity

Annual bonus

Medical benefits

Dental benefits

Vision benefits

PTO

Job summary

Orca Bio is building next-generation cell therapies and expanding manufacturing operations on the East Coast to ensure reliable delivery of high-precision products. The MSAT Process Engineer will oversee lifecycle management of clinical and commercial products, including process monitoring, validation, and CAPA, while supporting investigations and change controls.

Required are a B.S. in Engineering, 3+ years in GMP manufacturing (biologics or related), and strong problem-solving and

Qualifications

• B.S. in Engineering or related field.
• 3+ years of GMP manufacturing experience in biologics or related field.
• Experience with process monitoring, validation, and CAPA.

Responsibilities

• Monitor existing products and processes to ensure quality and efficiency.
• Generate metrics and reports for process monitoring and continuous verification.
• Support process changes and improvements including electronic batch record updates.
• Investigate process events and implement corrective/preventive actions.
• Provide troubleshooting for manufacturing events, equipment performance, and material issues.
• Own change controls, protocols, and reports for process improvements.
• Write and execute validation protocols in line with life cycle management activities.

Skills

Manufacturing processes

GMP experience

Biologics manufacturing

Cell therapy knowledge

Problem solving

Communication skills

Education

B.S. in Engineering

Bachelor's in related field

Job description

Orca Bio is building next-generation cell therapies and expanding manufacturing operations on the East Coast to ensure reliable delivery of high-precision products. The MSAT Process Engineer will oversee lifecycle management of clinical and commercial products, including process monitoring, validation, and CAPA, while supporting investigations and change controls.

Required are a B.S. in Engineering, 3+ years in GMP manufacturing (biologics or related), and strong problem-solving and