Description
We are looking for a skilled Validation Engineer to join our growing team. In this role, you will ensure our software systems meet quality standards and comply with regulatory requirements. This role is to help build and define its validation function from the ground up. As an early team member, you'll shape core processes, own key deliverables, and interface with many different teams across the organization to embed quality throughout the SDLC.
Responsibilities:
Lead software validation activities aligned with internal procedures and regulatory expectations (GxP, FDA, ISO).
Create and maintain validation documentation, including IQ/OQ scripts, validation plans, risk assessments, protocols, reports, and traceability matrices.
Review requirements and design specs for testability and proper controls.
Execute or review functional, integration, regression, UAT, and IQ/OQ testing.
Support change control and update validation documentation as systems evolve.
Collaborate closely with cross-functional partners to identify risks early and build quality into development.
Prepare validation materials for audits and inspections.
Continuously refine validation processes, templates, and tools for scale and efficiency
Requirements
Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related field, or equivalent practical experience.
Minimum of two years of experience in CSV, software validation, quality engineering, or QA within regulated or quality-driven environments.
Familiarity with Agile development methodologies, software testing practices, and quality frameworks.
Proven ability to draft and maintain validation and quality-related documentation.
Strong attention to detail with the capability to manage multiple tasks simultaneously.
Excellent written and verbal communication skills.
Knowledge of regulatory standards such as GxP, ISO 9001, or 21 CFR Part 11.
Experience working in cross-functional teams, particularly in dynamic product-focused environments.
Technology Doesn't Change the World, People Do.
Robert Half is the world's first and largest specialized talent solutions firm that connects highly qualified job seekers to opportunities at great companies. We offer contract, temporary and permanent placement solutions for finance and accounting, technology, marketing and creative, legal, and administrative and customer support roles.
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Robert Half will consider qualified applicants with criminal histories in a manner consistent with the requirements of the San Francisco Fair Chance Ordinance. All applicants applying for U.S. job openings must be legally authorized to work in the United States. Benefits are available to contract/temporary professionals, including medical, vision, dental, and life and disability insurance. Hired contract/temporary professionals are also eligible to enroll in our company 401(k) plan. Visit roberthalf.gobenefits.net for more information.
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Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
- Dice Id: rhalfint
- Position Id: 00410-0013397156
- Posted 3 hours ago
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