Senior Process Validation Engineer, Cell Therapy (Equity)

Orca-Bio; California (MO); On-site; USD 110,000 - 145,000; Full time

Benefits offered by this job

Pre-IPO equity

Annual bonus

Medical, dental, and vision benefits

PTO and 401(k)

Job summary

Orca Bio is seeking a Senior Process Validation Engineer in Sacramento, CA to own the Process Validation lifecycle including PVMP, PPQ, APS, and Shipping Validation. You will collaborate with Manufacturing, MSAT, CMC, QA, and Supply Chain to establish, verify, and maintain the validated state across cell therapy processing and shipping.

The role requires a degree in Chemical/Biomedical/Life Sciences and 4+ years (Master's 4+; Bachelor's 6+ years) in a cGMP environment, with PPQ/APS protocol

Qualifications

• cGMP knowledge and regulatory understanding.
• Technical writing and documentation skills.
• Cross-functional collaboration and project leadership.
• Strong problem solving and analytical abilities.

Responsibilities

• Own the PPQ campaigns strategy, execution, and documentation.
• Author and review PV Plans, Protocols, and Reports supporting stage 2 validation.
• Lead APS and shipping validation activities across cold-chain processes.
• Support audits and change controls with RCA and CAPA analyses.

Job description

Orca Bio is seeking a Senior Process Validation Engineer in Sacramento, CA to own the Process Validation lifecycle including PVMP, PPQ, APS, and Shipping Validation. You will collaborate with Manufacturing, MSAT, CMC, QA, and Supply Chain to establish, verify, and maintain the validated state across cell therapy processing and shipping.

The role requires a degree in Chemical/Biomedical/Life Sciences and 4+ years (Master's 4+; Bachelor's 6+ years) in a cGMP environment, with PPQ/APS protocol