Sr. Systems Validation Engineer

At Cellular Vehicles, our mission is to accelerate the advent of curative therapies, and ensure all patients have access to them.

What We Are Looking For

We are seeking a Senior Validation Engineer to lead our product from pilot-phase prototype to GMP-ready capital equipment and disposable kits. This role sits at the intersection of systems engineering, verification & validation, and quality/GMP compliance.

You will work closely with the founders, robotics, mechanical, and biology teams to:

• Understand the quality and regulatory framework that governs GMP medical equipment.
• Provide technical guidance and contribute to hands‑on builds and design changes to ensure the system is V&V ready.
• Plan and execute system‑level V&V and qualification activities.
• Build the lightweight but robust quality and documentation framework needed for GMP adoption of the Odyssey platform and its disposable kits.

This is a hands‑on role: you will need deep technical and quality/regulatory knowledge and be expected to both design and run tests yourself and build the processes and documentation that our biopharma partners and regulators require.

Responsibilities will include (but are not limited to):

• Own and maintain system‑level requirements for the Odyssey platform and disposable kits, linking clinical/user needs to engineering specifications.
• Build and maintain a requirements traceability matrix from user needs → system requirements → sub‑system requirements → test cases.
• Work with robotics, mechanical, software, and biology teams to ensure designs meet requirements and are testable and verifiable.
• Develop and execute V&V plans and protocols for capital equipment, disposables, and critical workflows (including system performance, reliability, usability, sterilization, biocompatibility, and user safety).
• Design and build test fixtures and test setups for system‑ and sub‑system‑level testing (life testing, stress testing, environmental, shipping, etc.).
• Analyze test data, summarize findings, and drive design iterations and risk mitigations based on results.
• Define and support IQ/OQ/PQ strategies for Odyssey deployments at partner sites; generate documentation that pharma QA teams can adopt.
• Map our current development activities to applicable GMP, ISO 13485, and ISO 14971 expectations for equipment and single‑use kits; identify and close gaps.
• Draft, implement, and maintain SOPs for incoming inspection, lot release, change control, deviation/CAPA, and basic document control.
• Lead or contribute to risk management activities (hazard analysis, DFMEAs, process FMEAs, risk control measures, and residual risk rationales).
• Support and, where appropriate, lead commissioning and qualification of key equipment and processes at our facility and at pilot customer sites.
• Prepare technical content for regulatory and quality packages (device description, V&V summaries, risk files, IQ/OQ/PQ packages) in collaboration with external regulatory consultants.
• Support customer audits and technical due diligence, representing the system, its risk controls, and our quality approach.
• Work closely with pharma partners’ QA, validation, and manufacturing groups to ensure Odyssey fits smoothly into their validation and GMP frameworks.
• Help mentor junior team members and interns on test design, documentation best practices, and quality mindset.
• Proactively identify and communicate risks, tradeoffs, and mitigation strategies to the founders and broader team.

What You’ll Bring

• BS or higher in Biomedical Engineering or related field.
• 7+ years of experience in medical device, biotech automation, or bioprocessing equipment, with at least one product taken from late‑stage development toward GMP use.
• Demonstrated experience owning system‑level V&V for complex electromechanical or automated systems (writing protocols, executing tests, analyzing data, and authoring reports).
• Hands‑on experience with validation/qualification activities (e.g., equipment/facility qualification, IQ/OQ/PQ, process validation or method validation).
• Working knowledge of key quality and regulatory frameworks, such as ISO 13485, ISO 14971, FDA QSR / relevant GMP expectations for equipment and single‑use…