Software Validation Engineer (TEMP) at 10x Genomics

Pleasanton, California, United States -

Full Time

Start Date

Immediate

Expiry Date

09 Mar, 26

Salary

0.0

Posted On

09 Dec, 25

Experience

0 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Software Quality Assurance, Computer System Validation, Spreadsheet Compliance, Validation Lifecycle, Change Control, Quality Management System, ISO 13485, Technical Aptitude, Programming Skills, Attention to Detail, Communication Skills, Compliance Focus, Agentic AI, ERP Systems, LIMS Systems, GxP

Industry

Biotechnology Research

Description

About the role: We are seeking a highly motivated and detail-oriented Software Quality Engineer (Temp) to join our Quality Assurance team. This position is a crucial part of our effort to ensure the compliance and reliability of our non-product, business-critical computerized systems. You will gain hands-on experience with Computer System Validation (CSV) within a regulated environment as we transition from ISO 9001 to ISO 13485. This role is ideal for individuals with manufacturing experience looking to start a career in specialized software validation and quality assurance within the medical device or life sciences industry. What you will be doing: Spreadsheet Compliance and Validation: Execute and document the full validation lifecycle for critical Microsoft Excel spreadsheets used in Quality Management System (QMS) processes. This includes comprehensive formula verification, macro review, access control setup, and ensuring compliance with data integrity principles and regulatory guidelines (e.g., GxP, 21 CFR Part 11). Change Control Assistance: Support the Senior SQA Engineer in managing and documenting changes to validated systems through the established Change Control process. Process Learning: Learn and follow established Quality Management System (QMS) procedures and protocols related to software validation, ISO 13485, and design control. Minimum Requirements: Bachelor's degree in Computer Science, Engineering, Quality Assurance, or a related technical/scientific field. Experience: 0–2 years of experience in a technical or quality assurance role. Direct experience in a regulated manufacturing or production environment (e.g., medical device, pharmaceutical, or life sciences) is highly preferred and will be strongly emphasized. Technical Aptitude: Excellent programming skills to execute test automation scripting (e.g., Python, scripting languages). Detail Orientation: Exceptional attention to detail with strong organizational skills, necessary for maintaining precise validation records. Communication: Excellent written and verbal communication skills, with the ability to articulate technical details clearly. Compliance Focus: A strong desire to work within a regulated environment and learn about quality standards such as ISO 13485 and ISO 9001. Preferred Skills and Experience: Hands-on experience with Agentic AI Familiarity with any ERP or LIMS system concepts. Basic understanding of GxP or FDA 21 CFR Part 11. #LI-MH1 #on-site 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.

Responsibilities

The Software Validation Engineer will execute and document the validation lifecycle for critical Microsoft Excel spreadsheets and support the Senior SQA Engineer in managing changes to validated systems. The role involves learning and following established Quality Management System procedures related to software validation.