Senior Cell Therapy Process Validation Engineer

Medium; Sacramento (CA); On-site; USD 110,000 - 145,000; Full time

Benefits offered by this job

Pre-IPO equity

Medical, dental, vision benefits

PTO and 401(k)

Subsidized lunches and snacks

Job summary

Orca Bio, a Sacramento-based cell therapy company, seeks a Senior Process Validation Engineer to own PPQ campaigns and validate processes across manufacturing and shipping. You will collaborate with MSAT, CMC, QA, and Supply Chain to maintain validated states for cell therapy products.

You will author and review PVMP-related documents, support APS activities, and drive CAPA investigations while ensuring compliance with FDA/EMA standards and GMP requirements.

Qualifications

• Bachelor’s or Master’s degree in chemical/biomedical engineering, biotechnology or life sciences.
• Direct experience writing and executing PPQ protocols/reports, APS protocols/reports, and shipping validation protocols.
• Strong understanding of cGMP regulations and validation standards (FDA 21 CFR Part 210/211, EU Annex 1, ICH Q8/Q9/Q10).

Responsibilities

• Own the strategy, execution, and documentation for PPQ campaigns.
• Author, review, and approve Process Validation Plans, Protocols, and Reports.
• Lead and execute Solution / In-Process Hold Studies and Mixing Studies to evaluate process limits and stability.

Skills

Process validation

cGMP compliance

Technical writing

QA collaboration

Education

Bachelor’s or Master’s degree in Chemical Engineering, Biomedical Engineering, Biotechnology or Life Sciences

Tools

JMP

Minitab

Job description

Orca Bio, a Sacramento-based cell therapy company, seeks a Senior Process Validation Engineer to own PPQ campaigns and validate processes across manufacturing and shipping. You will collaborate with MSAT, CMC, QA, and Supply Chain to maintain validated states for cell therapy products.

You will author and review PVMP-related documents, support APS activities, and drive CAPA investigations while ensuring compliance with FDA/EMA standards and GMP requirements.