Senior Engineer, Process Validation - Cell Therapy

Orca Bio is seeking a highly skilled Senior Process Validation Engineer to join our Validation group in Sacramento, CA. In this role, you will hold primary ownership over the Process Validation lifecycle—including overall Process Validation Master Plans (PVMP), Process Performance Qualification (PPQ), Aseptic Process Simulations (APS), and Shipping Validation.

You will work closely with Manufacturing (MFG), MSAT, CMC, Quality Assurance, and Supply Chain to establish, verify, and maintain the validated state across our cell therapy drug product processing and shipping channels.

Physical Demands

Work Conditions

Essential Duties & Key Responsibilities:

Process Qualification & PPQ Campaigns

• Own the strategy, execution, and documentation for PPQ campaigns.
• Author, review, and approve Process Validation Plans, Protocols, and Reports supporting Stage 2 validation activities.
• Lead and execute Solution / In-Process Hold Studies and Solution / In-Process Mixing Studies to evaluate process limits and solution stability.
• Develop and support PPQ campaigns, including authoring PPQ Protocols and Reports and conducting thorough verification of PPQ pre-requisites prior to execution.

Aseptic Process Simulation (APS)

• Serve as the document owner for all APS Protocols and Summary Reports.
• Write initial APS protocols and validation reports.
• Lead protocol revisions and updates driven by process or facility changes, with technical support from MSAT.
• Partner with Operations on execution: collaborate with MSAT/MFG during initial APS executions and transition routine APS execution ownership to Manufacturing while maintaining validation oversight.

Shipping Validation & Cold-Chain Management

• Hold end-to-end ownership of Shipping Validation across raw materials, intermediates, and final cell therapy drug products.
• Develop and maintain the Shipping Validation Master Plan (VMP).
• Author, execute, and report on Shipping Validation Protocols, Plans, and Summary Reports.
• Assess shipping impact for change controls, lane modifications, and transport system alterations.

Validation Governance & Core Authoring

• Maintain and own the facility’s Process Validation Master Plan (PVMP).
• Author User Requirement Specifications (URS), risk assessments (FMEAs), and assessments for new equipment, processing tools, and single-use technologies.
• Support deviation investigations, root-cause analyses (RCA), and lead validation impact assessments for CAPAs and change controls.
• Serve as a Subject Matter Expert (SME) during internal audits and regulatory inspections (FDA/EMA).

Minimum Qualifications:

Preferred Qualifications: