Senior Engineer, Process Validation - Cell Therapy

Job description

More than one million people in the United States today are fighting blood cancer. While a traditional allogeneic stem cell transplant has been the best hope for many, the transplant itself can prove fatal or lead to serious conditions, such as graft vs. host disease. Orca Bio is a commercial-stage biotechnology company redefining the transplant process by developing next-generation cell therapies with the goal of providing significantly better survival rates with dramatically fewer risks.With our purified, high-precision cell therapies we hope to not only replace patients' blood and immune systems with healthy ones, but also restore their lives. We have built a state-of-the-art, 100,000-square-foot manufacturing facility in Sacramento, CA (7910 Metro Air Pkwy) to ensure the consistent and reliable delivery of our high-precision cell therapy products. This site is essential to advancing our clinical pipeline and supporting future commercial availability of our life-saving therapies. **Position Summary:** 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 - *Production Associate Roles*: Must have visual acuity of 20/20 (corrected or uncorrected) and normal color vision to safely perform critical tasks such as visual inspection of materials, equipment, and labeling, including distinguishing color-coded components in a GMP environment. - *Most roles* must be able to meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for extended periods, as needed. Use of cosmetics (makeup, painted nails), jewelry, or facial piercings is not permitted in the cleanroom, and any skin conditions that cause shedding must be disclosed. - *Many roles* must be able to work at either Orca Bio Sacramento location (3400 Business Dr. or 7910 Metro Air Pkwy) based on operational needs, as well as regularly participate in video-based meetings. Also, may be required to work scheduled overtime, weekends, or holidays based on business needs. ### 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: - Bachelor’s or Master’s degree in Chemical Engineering, Biomedical Engineering, Biotechnology, Life Sciences, or a related discipline. - **Experience:** - - Bachelor’s degree with 6+ years of direct process validation experience in a cGMP environment OR - Master’s degree with 4+ years of direct process validation experience in a cGMP environment. - Direct experience writing and executing PPQ protocols/reports, APS protocols/reports, hold and mixing studies, and shipping validation protocols. - Solid understanding of cGMP regulations and validation standards (FDA 21 CFR Part 210/211, EU Annex 1, ICH Q8/Q9/Q10). - Strong technical writing capability with experience generating URS documents and process risk assessments. ### Preferred Qualifications: - Direct experience in cell therapy manufacturing (e.g., cell selection, expansion, aseptic processing, single-use systems, cryopreservation). - Background in cold-chain logistics, cryogenic shipping containers (LN2 dewars), and thermal performance testing (ISTA/ASTM standards). - Experience using statistical tools (e.g., JMP, Minitab) for process monitoring and capability analyses.