Senior CSV / CSA Validation Consultant

Digital Office - Kosice, Malaysia, Frankfurt, Boston

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Your profile / requirements

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, Biotechnology, Pharmaceutical Sciences, Quality Management, or a related field; a Master’s degree is considered an advantage 
• 5+ years of experience in Computer System Validation (CSV), Computer Software Assurance (CSA), digital validation, or compliance-related activities within regulated life sciences environments 
• Strong understanding of GxP regulations, GAMP 5, EU GMP Annex 11, 21 CFR Part 11, data integrity principles, risk-based validation approaches, and quality management systems 
• Experience working within pharmaceutical, biotechnology, and/or medical device environments 
• Experience validating GxP computerized systems and digital platforms across laboratory, manufacturing, quality, ERP, or cloud-based environments 
• Experience authoring and reviewing validation lifecycle documentation, including validation plans, requirements, risk assessments, test documentation, traceability matrices, deviations, change assessments, and validation reports 
• Understanding of software development lifecycle (SDLC), Agile/DevOps environments, automated testing, and modern CSA approaches is considered an advantage 
• Experience with AI/ML-enabled systems, cloud validation, Digital QC, medical device quality standards, or automated production systems is considered an advantage 
• Experience supporting audits, inspections, supplier assessments, CAPA activities, data integrity initiatives, or compliance remediation programs is considered an advantage 
• Strong communication and stakeholder management skills with the ability to work in international and cross-functional environments 
• Ability to work independently, manage customer interactions, and contribute to both technical and business discussions  
• Interest in supporting customer workshops, service development, and business growth initiatives 

Tasks and responsibilities

• Lead and support Computer System Validation (CSV), Computer Software Assurance (CSA), and digital validation activities within regulated life sciences environments 
• Support validation and compliance activities for computerized systems, digital platforms, laboratory and manufacturing systems, equipment software, and emerging technologies, including AI-enabled solutions 
• Collaborate with customers and internal stakeholders to define validation strategies, risk-based approaches, and compliant delivery models aligned with GxP expectations 
• Author, review, and support the execution of validation lifecycle documentation, including validation plans, risk assessments, test documentation, traceability matrices, and validation summary reports 
• Support validation and compliance initiatives across pharmaceutical, biotechnology, and medical device projects 
• Contribute to modern software validation approaches, including automated testing, digital validation methods, and CSA-aligned practices 
• Support customer workshops, assessments, audits, inspection readiness activities, and strategic compliance discussions 
• Collaborate with international delivery teams across Europe, APAC, and the US to support project execution, knowledge sharing, and service development initiatives 
• Support business development activities by contributing to customer engagements, proposals, workshops, and technical solution discussions 
• Share knowledge and contribute to capability development within the validation and compliance community at Arcondis 

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