Senior Software Validation Engineer, Manufacturing

Senior Software Validation Engineer, Manufacturing

Pleasanton, California, USA HQ

We are seeking a highly experienced and efficient Senior Software Validation Engineer, Manufacturing to join our Quality team. This critical role focuses on the validation and compliance of non-product, business‑critical computerized systems in our regulated environment. The ideal candidate will have deep expertise in Computer System Validation (CSV) within design‑controlled industries, ISO 9001 and ISO 13485 with a strong drive to automate all manual processes for increased effectiveness and reliability.

• Automated Testing:
  Develop, implement, and maintain test scripts using appropriate tools to automate testing and regression testing for validated systems, increasing efficiency and repeatability.
• Utilize agentic AI and LLM’s to design and develop tools that increase process efficiency
• Computer System Validation (CSV):
  Lead and execute all activities related to the validation lifecycle of non‑product software systems, ensuring compliance with internal procedures, ISO 13485 (future state), and relevant regulatory requirements.
• System Validation Expertise:
  Act as the subject matter expert for the validation of essential corporate systems, which may include:
  • Production software (LIMS, eQMS, etc.).
  • Spreadsheet Validation (e.g., Microsoft Excel) used for critical manufacturing and quality control processes.
• Process Documentation:
  Author, review, and approve validation documentation, including Validation Plans (VP), User Requirements Specifications (URS), Functional Specifications (FS), Traceability Matrices (TM), Test Protocols (IQ/OQ/PQ), and Validation Reports (VR).
• Compliance & Audits:
  Ensure all validation activities and system documentation are maintained in an "audit‑ready" state. Participate in internal and external audits (e.g., ISO, regulatory body inspections) as the CSV expert.
• Change Control:
  Manage validation efforts related to system updates, patches, configurations, and major upgrades through the established Change Control process.
• Technical
  
  Skills:
  
  Proficiency in writing automation scripts in Python and using software testing tools to drive efficient, repeatable testing.
• Experience:
  
  5 years of experience in Software Quality Assurance AND Computer System Validation (CSV) in a regulated, design‑controlled industry (e.g., Medical Devices, Pharmaceuticals, Biotechnology).
• Regulatory Knowledge:
  Demonstrated, in‑depth understanding of ISO 13485 (or strong experience with an equivalent quality standard like FDA 21 CFR Part 820 or 21 CFR Part 11). Current experience in an ISO 9001 environment is a plus.
• Documentation
  
  Skills:
  
  Exceptional technical writing skills with the ability to create clear, concise, and compliant validation documentation.
• Education:
  
  Bachelor's degree in Computer Science, Engineering or a related technical field.

• Hands‑on experience with AI and LLM's
• Basic understanding of GxP or FDA 21 CFR Part 11
• System Proficiency:
  Proven, hands‑on experience validating commercial off‑the‑shelf (COTS) and configured software, specifically ERP systems (e.g., SAP, Oracle, Net Suite, etc.), LIMS, and complex spreadsheet validation.

Below is the base pay range for this full‑time position. The actual base pay will depend on several factors unique to each candidate, including one’s skills, qualifications, and experience. At 10x, base pay is also just one component of the Company’s total compensation package. This role is also eligible for 10x’s equity grants, its comprehensive health and retirement benefit programs, and its annual bonus program or sales incentive program.

During the hiring process, your 10x recruiter can share more about the Company’s total compensation package.

$165,800 - $224,400 USD

At 10x Genomics, accelerating our understanding of biology is more than a mission for us. It is a commitment. This is the century of biology, and the breakthroughs we make now have the potential to change the world. We enable scientists to advance their research, allowing them to address scientific questions they did not even know they could ask. Our tools…