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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.
Job Responsibility:
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