At a Glance
- Tasks: Lead validation of GxP systems and author essential documentation.
- Company: Join a leading company in the pharma and biotech industry.
- Benefits: Competitive salary, health benefits, and opportunities for professional growth.
- Other info: Dynamic role with a focus on innovation and collaboration.
- Why this job: Make a real impact in ensuring system compliance and data integrity.
- Qualifications: 5+ years in Computer System Validation and strong technical writing skills.
The predicted salary is between 82800 - 101200 $ per year.
The CSV Validation Engineer will serve as a senior subject-matter expert responsible for the end-to-end validation of GxP-regulated computerized systems. This hands-on role focuses on assessing validation status, defining risk-based validation strategies, and authoring all required documentation — from discovery through execution — across a diverse portfolio of enterprise, laboratory, manufacturing, and quality systems.
Key Responsibilities
- Lead risk-based validation planning and execution for GxP systems throughout their lifecycle.
- Author core validation deliverables (Validation Plans, URS, Risk Assessments, IQ/OQ/PQ protocols & reports, Traceability Matrices, Validation Summary Reports, Decommissioning Plans).
- Conduct impact assessments for system changes, incidents, upgrades, and releases; generate Software Compliance Assessments and Change Requests.
- Perform periodic reviews, data-integrity assessments, and audit-trail evaluations covering the full data lifecycle.
- Manage test execution documentation, evidence collection, and, when required, review source code or configuration.
- Provide CSV expertise during vendor selection, qualification, and ongoing vendor-managed validation activities.
- Advise project teams, system owners, IT, and quality stakeholders on GxP validation requirements and best practices.
- Support decommissioning of retired systems and closure of associated validation records.
- Utilize Jira for test management, defect tracking, requirements traceability, and project coordination.
- Align all work with the organization’s validation templates, SDLC, and quality system standards.
Job Requirements
- 5+ years of hands-on Computer System Validation experience in a GxP-regulated environment (pharma, biotech, or medical-device).
- Proven track record of personally authoring validation deliverables such as URS, Risk Assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Validation Summary Reports.
- Direct experience leading periodic system reviews and conducting data-integrity/audit-trail assessments.
- Demonstrated ability to evaluate and document the impact of system changes, upgrades, and incidents on validated state.
- Working fluency in GAMP 5 categories, 21 CFR Part 11, and EU GMP Annex 11; comfortable discussing ICH guidelines and data-integrity principles without reference material.
- Strong technical writing skills; ability to produce clear, audit-ready documentation independently.
- Bachelor’s degree in Computer Science, Information Technology, Engineering, or a related discipline, or equivalent professional experience.
- Advanced English proficiency (C1 level) – required for documentation, stakeholder communication, and regulatory interactions.
CSV Validation Engineer in Québec employer: Stefanini LATAM
As a CSV Validation Engineer, you will thrive in a dynamic work environment that prioritizes innovation and compliance within the GxP-regulated landscape. Our company fosters a collaborative culture where your expertise is valued, offering ample opportunities for professional growth and development. Located in a vibrant area, we provide competitive benefits and a supportive atmosphere that encourages work-life balance, making us an exceptional employer for those seeking meaningful and rewarding careers.
