Senior CSV / CSA Validation Consultant

Key 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

Qualifications, Skills and Experience

• 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
• 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
• Able 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