Senior Engineer, Process Validation - Cell Therapy

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 Associates: 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.

Must meet cleanroom gowning requirements, including wearing full gowning (face coverings, gloves, hoods, goggles) for up to 3 consecutive hours at a time, minimal movement in the cleanroom, and working with or around human blood, blood-derived materials, cells, other biological materials, and alcohol-based sprays. 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.

Must be comfortable regularly participating in video-based meetings.

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.

The anticipated annual salary range (listed above) for this job is based on prior experience in the role/industry, education, location, internal equity, and other job-related factors as permitted by law. For remote-based positions, this range may vary based on your local market. Full-time employment positions will also be eligible to receive pre-IPO equity and annual bonus, in addition to competitive medical, dental, and vision benefits, PTO, 401(k) plan, life and accidental death and disability coverage, and parental leave benefits. Other perks include subsidized daily lunches and snacks at our on-site locations.   Who we are   We are driven by a passion for science and compassion for patients. We act with urgency to ensure our treatments are one day accessible to all who need them.   We live by our core values of passion, courage, and integrity. Excellence in our work means the chance to unlock a better quality of life for our patients, and with that comes tremendous responsibility.   We innovate on a path that hasn’t been paved. We embrace an entrepreneurial spirit and take calculated risks to achieve our mission. We aren’t afraid to ask “why not” and challenge the status quo.   We maintain a start-up culture of camaraderie and leadership by example, regardless of title.   We’re proud to be an equal opportunity employer, and recognize that celebrating our differences creates stronger, lasting solutions that better serve our team, our patients and their healthcare providers.   Notice to staffing firms   Orca Bio does not accept resumes from staffing agencies with which we do not have a written agreement and specific engagement for a particular opening. Our employment activities, inquiries and offers are managed through our HR/Talent team, and all candidates are presented through this channel only. We do not accept unsolicited resumes, and we rarely outsource recruitment.