We are looking for a skilled Validation Engineer to join our team in San Francisco, California. In this role, you will ensure that software systems meet established quality standards and adhere to regulatory requirements. You will work closely with cross-functional teams to design, execute, and maintain validation activities throughout the software development lifecycle. This position requires someone with keen attention to detail who is committed to improving processes and ensuring compliance. Responsibilities:• Plan and execute software validation activities in alignment with company procedures and regulatory standards.• Develop and maintain validation documentation, including plans, test protocols, reports, and risk assessments.• Analyze system requirements, design specifications, and user stories to confirm testability and compliance.• Conduct and review functional, integration, regression, and user acceptance testing.• Assess validation impacts during change control activities and update related documentation accordingly.• Collaborate with engineering and product teams to identify risks and integrate quality measures during development.• Prepare and provide documentation for audits and inspections, offering support as needed.• Implement improvements to validation processes, templates, and tools for enhanced efficiency.• Support customer or internal audits by contributing to validation-related responses and documentation.An emerging technology leader in the regulated software space is hiring its first dedicated Quality Engineer. This is a rare opportunity to build a Quality Management System (QMS) from the ground up, shape internal quality culture, and directly influence the company’s ability to win customers in regulated industries such as pharma, biotech, medical devices, and specialty chemicals.If you thrive in early‑stage environments, enjoy creating structure where none exists, and want real ownership and impact, this role offers all of that—and a direct line to leadership.U.S. work authorization required; sponsorship is not available.What You’ll Own:• Design, implement, and maintain a QMS aligned with ISO 9001, ISO 13485, 21 CFR Part 11, and GAMP 5.• Develop SOPs, work instructions, quality plans, and validation protocols (IQ/OQ/PQ).• Lead software validation efforts for customers operating in regulated environments.• Partner with Sales and Customer Success on quality questionnaires, RFPs, and customer audit needs.• Support customer audits; serve as the internal SME on compliance topics.• Own supplier quality, including vendor qualification and assessments.• Drive continuous improvement across processes, documentation, and tools.• Build quality training programs and foster a quality‑first mindset across teams.

.What We’re Looking For:• 2+ years in quality engineering, QA, or compliance—ideally in software, SaaS, or SaMD.• Experience in regulated industries (pharma, biotech, med‑device, specialty chemicals).• Knowledge of 21 CFR Part 11, GAMP 5, ISO 9001/13485.• Hands‑on CSV or software validation experience (IQ/OQ/PQ).• Strong communication and documentation skills.• Self‑starter comfortable building new processes.Nice to Have:• Startup or fast‑paced SaaS experience.• Pre‑sales or solutions support for regulated customers.• Familiarity with ELN or R&D platforms.

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San Francisco, CA
remote
Permanent
100000 - 120000 USD / Yearly
We are looking for a skilled Validation Engineer to join our team in San Francisco, California. In this role, you will ensure that software systems meet established quality standards and adhere to regulatory requirements. You will work closely with cross-functional teams to design, execute, and maintain validation activities throughout the software development lifecycle. This position requires someone with keen attention to detail who is committed to improving processes and ensuring compliance. Responsibilities:• Plan and execute software validation activities in alignment with company procedures and regulatory standards.• Develop and maintain validation documentation, including plans, test protocols, reports, and risk assessments.• Analyze system requirements, design specifications, and user stories to confirm testability and compliance.• Conduct and review functional, integration, regression, and user acceptance testing.• Assess validation impacts during change control activities and update related documentation accordingly.• Collaborate with engineering and product teams to identify risks and integrate quality measures during development.• Prepare and provide documentation for audits and inspections, offering support as needed.• Implement improvements to validation processes, templates, and tools for enhanced efficiency.• Support customer or internal audits by contributing to validation-related responses and documentation.An emerging technology leader in the regulated software space is hiring its first dedicated Quality Engineer. This is a rare opportunity to build a Quality Management System (QMS) from the ground up, shape internal quality culture, and directly influence the company’s ability to win customers in regulated industries such as pharma, biotech, medical devices, and specialty chemicals.If you thrive in early‑stage environments, enjoy creating structure where none exists, and want real ownership and impact, this role offers all of that—and a direct line to leadership.U.S. work authorization required; sponsorship is not available.What You’ll Own:• Design, implement, and maintain a QMS aligned with ISO 9001, ISO 13485, 21 CFR Part 11, and GAMP 5.• Develop SOPs, work instructions, quality plans, and validation protocols (IQ/OQ/PQ).• Lead software validation efforts for customers operating in regulated environments.• Partner with Sales and Customer Success on quality questionnaires, RFPs, and customer audit needs.• Support customer audits; serve as the internal SME on compliance topics.• Own supplier quality, including vendor qualification and assessments.• Drive continuous improvement across processes, documentation, and tools.• Build quality training programs and foster a quality‑first mindset across teams.
2026-03-06T00:00:00Z

Validation Engineer Job in San Francisco, CA | Robert Half