Senior CSV / CSA Validation Consultant

Overview

The Senior CSV / CSA Validation Consultant supports international life sciences projects across pharmaceutical, biotechnology and medical device environments. The role leads Computer System Validation, Computer Software Assurance and digital compliance activities for digital systems, laboratory and manufacturing platforms, equipment software and emerging technologies in regulated GxP environments.

Key Responsibilities

• Lead and support Computer System Validation, Computer Software Assurance and digital validation activities within regulated life sciences environments.
• Validate computerised systems, digital platforms, laboratory and manufacturing systems, equipment software and emerging technologies, including AI-enabled solutions.
• Work with clients and internal stakeholders to define validation strategies, risk-based approaches and compliant delivery models.
• Author, review and support the execution of validation plans, risk assessments, test documentation, traceability matrices and validation summary reports.
• Apply modern validation practices, including automated testing, digital validation methods and CSA-aligned approaches.
• Support client workshops, assessments, audits, inspection readiness and strategic compliance discussions.
• Collaborate with international delivery teams across Europe, APAC and the United States on project execution, knowledge sharing and service development.
• Contribute to client engagements, proposals, workshops and technical solution discussions.
• Share knowledge and support capability development within Arcondis’ validation and compliance community.

Requirements

Qualifications

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, Biotechnology, Pharmaceutical Sciences, Quality Management or a related field.

Skills

• Strong communication, stakeholder-management and workshop-facilitation skills.
• Ability to work independently and manage customer interactions.
• Ability to contribute to technical, compliance and business discussions.
• Ability to work effectively in international and cross-functional environments.
• Professional English proficiency for global client and project work.

Experience and Knowledge

• More than 5 years of experience in Computer System Validation, Computer Software Assurance, digital validation or compliance within regulated life sciences environments.
• Strong knowledge of GxP regulations, GAMP 5, EU GMP Annex 11, 21 CFR Part 11, data integrity, risk-based validation and quality management systems.
• Experience within pharmaceutical, biotechnology and/or medical device environments.
• Experience validating GxP computerised systems and digital platforms across laboratory, manufacturing, quality, ERP or cloud environments.
• Experience authoring and reviewing validation lifecycle documentation, including requirements, risk assessments, test documentation, traceability matrices, deviations, change assessments and reports.

Advantageous

• Master’s degree in a relevant discipline.
• Understanding of software development lifecycles, Agile or DevOps environments, automated testing and modern CSA approaches.
• Experience with AI or machine-learning-enabled systems, cloud validation, Digital QC, medical device quality standards or automated production systems.
• Experience supporting audits, inspections, supplier assessments, CAPA activities, data-integrity initiatives or compliance-remediation programmes.
• German language skills for EU and DACH customer engagements.