We are seeking a highly experienced and efficient Senior Software Quality Assurance (SQE) Engineer 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.
What you will be doing
- 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.
Minimum Requirements
- 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.
Preferred Skills & Experience
- Hands-on experience with Agentic AI and LLM
- 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, NetSuite, 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.
About 10x Genomics
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 have enabled fundamental discoveries across biology including cancer, immunology, and neuroscience.
Our teams are empowered and encouraged to follow their passions, pursue new ideas, and perform at their best in an inclusive and dynamic environment. We know that behind every scientific breakthrough, there is a deep infrastructure of talented people driving the life sciences industry and making it possible for scientists and clinicians to make new strides. We are dedicated to finding the very best person for every aspect of our work because the innovations and discoveries that we enable together will lead to better technologies, better treatments, and a better future. Find out how you can make a 10x difference.
Individuals seeking employment at 10x Genomics are considered without regards to race, color, religion, national origin, age, sex, marital status, ancestry, physical or mental disability, veteran status, gender identity, or sexual orientation, or any other characteristic protected by applicable law.
10x does not accept unsolicited applicants submitted by third-party recruiters or agencies. Any resume or application submitted to 10x without a vendor agreement in place will be considered unsolicited and property of 10x, and 10x will not pay a placement fee.
