Validation Engineer Job at Robert Half (San Francisco)

Validation Engineer

Robert Half

Location:
United States , San Francisco

Category:
IT - Software Development

Contract Type:
Not provided

Salary:

Not provided

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Job Description:

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. 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.

Job Responsibility:

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
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

Requirements:

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
U.S. work authorization required
sponsorship is not available

Nice to have:

Startup or fast‑paced SaaS experience
Pre‑sales or solutions support for regulated customers
Familiarity with ELN or R&D platforms

What we offer:

medical, vision, dental, and life and disability insurance
eligible to enroll in our company 401(k) plan

Additional Information:

Job Posted:
March 14, 2026

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