Senior Validation Engineer

We are looking for an experienced Validation & Compliance / Computer System Validation (CSV) professional with strong expertise in GxP-regulated environments and system decommissioning.
Key Responsibilities:
Lead and support Computer System Validation (CSV) activities across the full software lifecycle.
Develop and execute validation strategies, test cases, test plans, and validation documentation using the V-Model.
Perform IT Risk Assessments, Functional/Design Requirements, Implementation Plans & Reports.
Coordinate testing, validation, defect management, releases, and compliance activities.
Drive GxP and non-GxP system decommissioning activities independently.
Ensure systems meet Quality & Compliance requirements and regulatory guidelines.
Maintain configuration documents, system descriptions, SOPs, and audit-ready documentation.
Participate in Periodic Reviews, system evaluations, configuration reviews, and user reviews.
Support internal and external audits and provide CSV/validation expertise.
Collaborate with System Managers, System Owners, QA, LoB stakeholders, and Project Owners.
Support onboarding of new systems into ServiceNow and NovoAccess.
Must-Have Skills:
7+ years of IT experience
6+ years of GxP experience
Strong Computer System Validation (CSV) / Validation & QC expertise
Experience with V-Model and Software Development Life Cycle (SDLC)
Experience in GxP and non-GxP system decommissioning
Validation documentation and test strategy expertise
Risk assessment, requirements, testing, and defect management
Strong stakeholder management and communication skills
Ability to work independently and drive validation/decommissioning initiatives
Good to Have:
Validation & Regulatory Compliance experience within Pharma R&D
Experience working with ServiceNow
Knowledge of pharmaceutical quality systems and regulatory expectations

Work arrangement
No