Senior CSV / CSA Validation Consultant

Arcondis AG seeks a Senior CSV/CSA Validation Consultant to lead validation activities and ensure compliance for life sciences clients across regulated environments.

This position focuses on guiding validation efforts within the life sciences sector, specifically supporting projects in pharmaceuticals, biotechnology, and medical devices. The consultant ensures that computerized systems and digital platforms meet strict regulatory standards while helping clients navigate compliance challenges.

Responsibilities

• Direct and assist with Computer System Validation (CSV), Computer Software Assurance (CSA), and broader digital validation projects.
• Provide validation and compliance support for laboratory systems, manufacturing equipment software, digital platforms, and emerging technologies such as AI solutions.
• Partner with internal teams and clients to establish validation strategies, risk-based methodologies, and delivery models that align with GxP requirements.
• Create, review, and help execute validation documentation throughout the lifecycle, including plans, risk assessments, test scripts, traceability matrices, and summary reports.
• Promote modern validation techniques, including automated testing and CSA-aligned practices.
• Facilitate customer workshops, prepare for audits and inspections, and engage in strategic compliance conversations.
• Work with global delivery teams in Europe, APAC, and the US to execute projects, share knowledge, and develop services.
• Assist in business development by participating in client engagements, proposal writing, and technical solution discussions.
• Mentor colleagues and contribute to the growth of validation expertise within the organization.

Requirements

• Bachelor’s degree in Engineering, Computer Science, Life Sciences, Biotechnology, Pharmaceutical Sciences, Quality Management, or a related discipline.
• At least five years of experience in CSV, CSA, digital validation, or compliance roles within regulated life sciences settings.
• Deep knowledge of GxP regulations, GAMP 5, EU GMP Annex 11, 21 CFR Part 11, data integrity principles, risk-based validation, and quality management systems.
• Prior experience working in pharmaceutical, biotechnology, or medical device industries.
• Proven track record of validating GxP computerized systems and digital platforms in laboratory, manufacturing, quality, ERP, or cloud environments.
• Experience writing and reviewing validation lifecycle documents, such as plans, requirements, risk assessments, test records, traceability matrices, deviations, change assessments, and reports.
• Excellent communication and stakeholder management abilities, with experience collaborating in international and cross-functional teams.
• Capability to work autonomously, manage client relationships, and contribute to both technical and business discussions.

Nice to have

• A Master’s degree is viewed as a positive asset.
• Familiarity with SDLC, Agile/DevOps methodologies, automated testing, and modern CSA approaches.
• Experience with AI/ML-enabled systems, cloud validation, Digital QC, medical device quality standards, or automated production systems.
• Background in supporting audits, inspections, supplier assessments, CAPA activities, data integrity initiatives, or compliance remediation programs.
• Interest in driving customer workshops, service development, and business growth.

About the company

Arcondis AG operates within the Digital Office team, focusing on delivering specialized validation and compliance services to the life sciences industry.

• The role is integrated into the Digital Office team, fostering collaboration on digital validation initiatives.