Key Skills

Job Description

As our Validation Specialist IT (CSV/CSA), you will lead validation and compliance activities for GxP-regulated systems, digital transformation initiatives, equipment, infrastructure, and system integration projects across Prothya. Your role is responsible for defining validation strategies, ensuring regulatory compliance, and providing validation leadership across the project and system lifecycle. Working closely with Quality, IT, Engineering, Manufacturing, and external partners, you ensure solutions are implemented in accordance with established validation frameworks, CSV/CSA principles, Data Integrity requirements, and applicable regulations while supporting digital transformation initiatives. Key Responsibilities: 1. Validation Strategy & Compliance Define and execute risk-based validation strategies for GxP-relevant systems and projects aligned with established CSV/CSA frameworks, standards, and procedures. Ensure compliance with GxP, Data Integrity, EU GMP Annex 11, FDA 21 CFR Part 11, and company procedures. Support audits, inspections, and compliance assessments. 2. System & Project Validation Lead validation activities for system implementations, upgrades, integrations, and digital transformation initiatives. Review business requirements, functional specifications, configurations, and system designs from a validation perspective. Ensure validation requirements are embedded into project plans and delivery activities. Provide validation oversight for both IT and OT systems where applicable. 3. Validation Documentation & Lifecycle Management Author, review, and approve validation deliverables, including Validation Plans, Risk Assessments, Traceability Matrices, IQ/OQ/PQ protocols, and Validation Summary Reports. Ensure validation documentation is complete, traceable, inspection-ready and maintained throughout the system lifecycle. 4. Quality & Risk Management Perform system impact assessments and risk assessments. Support change controls, deviations, CAPAs, and incident investigations. Drive continuous improvement and standardisation of validation practices 5. Stakeholder & Vendor Collaboration Provide expert guidance to Quality, IT, Engineering, Manufacturing, and Business teams. Coach and mentor project teams on validation best practices, and coordinate validation activities with vendors, consultants, and implementation partners. Collaborate with Lead CSV representatives and Quality stakeholders to ensure alignment with validation standards and governance expectations. Core Competencies: Computer System Validation (CSV) and Computer Software Assurance (CSA) GxP and Data Integrity compliance Validation lifecycle management Risk-based decision making Audit and inspection readiness Stakeholder management and influencing skills Leadership and mentoring Technical writing and documentation Your profile: Professional / Educational Background: Bachelor's or Master's degree in Engineering, Life Sciences, Information Technology, Computer Science, or related discipline. Validation, GAMP, CSV, CSA, or Quality-related certifications are advantageous. >8 years of relevant experience in Computer System Validation, Compliance, Quality Systems, or Validation Engineering, including leadership responsibilities. Functional / Industry Experience: Experience in pharmaceutical, biotech, life sciences, or GMP manufacturing environments. Strong knowledge of GAMP 5, CSA principles, FDA 21 CFR Part 11, EU GMP Annex 11, and Data Integrity requirements. Experience with SAP, MasterControl, MES, LIMS, QMS, workflow platforms, and integrated digital solutions. Exposure to both IT and OT validation activities is highly desirable. Relevant Skills & Experience: Proven experience leading CSV and CSA activities in regulated environments. Experience validating enterprise systems, manufacturing systems, and system integrations. Strong understanding of validation lifecycle management, risk assessment, change control, and compliance governance. Experience supporting audits, inspections, and quality assessments. Experience managing vendors and validation service providers. Other Requirements: Ability to work effectively across Quality, IT, Engineering, Manufacturing, and Business functions. Comfortable operating independently while providing validation leadership across multiple projects. Strong focus on compliance, quality, continuous improvement, and cross-functional collaboration. Why This Role? Lead validation and compliance activities for strategic digital transformation initiatives. Work across IT, OT, Quality, Engineering, and Manufacturing domains. Play a key role in ensuring compliance, inspection readiness, and successful adoption of digital technologies. What we offer: Full-time employment (40h) with flexible working hours in consultation. Working part-time can be discussed. Salary between € 5.290,02 and € 7.604,37 gross per month (based on full-time employment). 8.33% holiday allowance and a 13th month. 30 holiday days (based on fte). A personal training budget of €2,100 every three years to foster professional growth and development. Contribution to travel expenses from the first kilometer. Excellent accessibility by public transport and private parking available. A pension plan with Zorg & Welzijn, providing security for your future. Acquisitie wordt niet op prijs gesteld. Prothya aanvaardt geen ongevraagde hulp van bureaus voor deze vacature. Toegestuurde cv's (in welke vorm dan ook) door bemiddelingsbureaus aan enige medewerker van Prothya zonder geldige schriftelijke zoekopdracht, worden gezien als eigendom van Prothya waarvoor op geen enkele wijze een vergoeding verschuldigd is.

Core Responsibilities

You will lead validation and compliance activities for GxP-regulated systems, digital transformation initiatives, and infrastructure projects. This includes defining risk-based validation strategies, managing documentation, and ensuring alignment with regulatory standards like FDA 21 CFR Part 11 and EU GMP Annex 11.

Requirements

Candidates must hold a Bachelor's or Master's degree in Engineering, Life Sciences, or IT with over 8 years of relevant experience in validation or compliance. Strong knowledge of GAMP 5, CSV/CSA principles, and experience in pharmaceutical or biotech manufacturing environments is required.

Benefits

• Flexible working hours
• Holiday allowance
• 13th month salary
• 30 holiday days
• Personal training budget
• Travel expenses contribution
• Public transport accessibility
• Private parking
• Pension plan