Senior Process Validation Engineer — Cell Therapy

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

Benefits offered by this job

Pre-IPO equity

Annual bonus

Medical, dental, vision benefits

401(k) plan

Job summary

Orca Bio in Sacramento, CA, is seeking a Senior Process Validation Engineer to own PPQ campaigns and lead validation across cell-therapy processing and shipping. You will partner with MFG, MSAT, CMC, QA, and Supply Chain to ensure validated state throughout the manufacturing and distribution network.

The role requires strong cGMP expertise, hands-on PPQ/APS protocol experience, and governance of PVMP and URS.

Qualifications

• Bachelor’s or Master’s degree in Chemical Engineering, Biomedical Engineering, Biotechnology, Life Sciences, or a related discipline.
• Direct experience writing and executing PPQ protocols/reports, APS protocols/reports, hold and mixing studies, 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).
• Solid technical writing capability with URS and risk assessments.

Responsibilities

• Own the strategy, execution, and documentation for PPQ campaigns.
• Author, review, and approve PV plans, protocols, and reports for Stage 2 validation.
• Lead and execute hold/mixing/APS studies to evaluate process limits and stability.
• Develop and support PPQ campaigns, including authoring PPQ Protocols/Reports and verifying pre-requisites.

Skills

Technical writing

Process validation

cGMP knowledge

Regulatory experience

Cross-functional collaboration

Education

Bachelor’s or Master’s degree in Chemical/Biomedical/Biotech/Life sciences

Tools

JMP

Minitab

Job description

Orca Bio in Sacramento, CA, is seeking a Senior Process Validation Engineer to own PPQ campaigns and lead validation across cell-therapy processing and shipping. You will partner with MFG, MSAT, CMC, QA, and Supply Chain to ensure validated state throughout the manufacturing and distribution network.

The role requires strong cGMP expertise, hands-on PPQ/APS protocol experience, and governance of PVMP and URS.