10x Genomics · 4 days ago
Senior Software Validation Engineer, Manufacturing
Pleasanton, CA
Full-time
Onsite
Senior Level
$166K/yr - $224K/yr
5+ years exp10x Genomics is seeking a highly experienced Senior Software Validation Engineer to join their Quality team. This role focuses on the validation and compliance of non-product computerized systems in a regulated environment, ensuring efficiency and reliability through automation and adherence to ISO standards.
Biotechnology
Responsibilities
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
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
Act as the subject matter expert for the validation of essential corporate systems, which may include: Enterprise Resource Planning (ERP) Systems (i.e. Salesforce, Oracle). Production software (LIMS, eQMS etc.). Spreadsheet Validation (e.g., Microsoft Excel) used for critical manufacturing and quality control processes
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)
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
Manage validation efforts related to system updates, patches, configurations, and major upgrades through the established Change Control process
Qualification
Required
Proficiency in writing automation scripts in Python and using software testing tools to drive efficient, repeatable testing
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)
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
Exceptional technical writing skills with the ability to create clear, concise, and compliant validation documentation
Bachelor's degree in Computer Science, Engineering or a related technical field
Preferred
Hands-on experience with AI and LLM's
Basic understanding of GxP or FDA 21 CFR Part 11
Proven, hands-on experience validating commercial off-the-shelf (COTS) and configured software, specifically ERP systems (e.g., SAP, Oracle, NetSuite, etc.), LIMS, and complex spreadsheet validation
Benefits
Equity grants
Comprehensive health and retirement benefit programs
Annual bonus program or sales incentive program
Company
10x Genomics
Cells are the basic unit of life.
1001-5000 employees
H1B Sponsorship
10x Genomics has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (41)
2024 (40)
2023 (35)
2022 (52)
2021 (34)
2020 (16)
Funding
Current Stage
Late StageLeadership Team
Serge Saxonov
Co-founder and CEO
Eric Whitaker
Executive Vice President and Chief Legal Officer
Recent News
2024-05-07
2024-04-30
2024-04-08
Company data provided by crunchbase