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10x Genomics · 1 day ago

Senior Software Validation Engineer, Manufacturing

Pleasanton, CA

Full-time

Onsite

Senior Level

$166K/yr - $224K/yr

5+ years exp

10x Genomics is dedicated to accelerating our understanding of biology and enabling scientists to advance their research. They are seeking a Senior Software Validation Engineer, Manufacturing to focus on the validation and compliance of business-critical computerized systems in a regulated environment, ensuring adherence to ISO standards and enhancing process efficiency through automation.

Biotechnology

H1B Sponsor Likely

Responsibilities

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: + 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

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

Qualification

Computer System Validation (CSV)ISO 13485PythonAutomated TestingERP SystemsTechnical WritingAILLM'sGxP KnowledgeSpreadsheet Validation

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

Glassdoor3.5

Cells are the basic unit of life.

Founded in 2012

Pleasanton, California, US

1001-5000 employees

http://10xgenomics.com

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 (25)

2024 (46)

2023 (37)

2022 (53)

2021 (34)

2020 (16)