Job Overview
We are looking for a Senior CSV / CSA Validation Consultant to strengthen and expand Arcondis capabilities in Computer System Validation (CSV), Computer Software Assurance (CSA), and digital compliance services within the life sciences industry.
In this role, you will support international projects across pharmaceutical, biotechnology, and medical device environments, helping customers validate digital systems, laboratory and manufacturing platforms, equipment software, and emerging technologies within regulated GxP environments.
You will contribute to project delivery, customer-facing advisory activities, and the continued evolution of modern validation approaches, including risk-based validation, digital quality, and AI-enabled technologies.
This position offers the opportunity to work closely with global teams across Europe, APAC, and the US while supporting customers in solving complex compliance and validation challenges in an increasingly digital environment.
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
- Share knowledge and contribute to capability development within the validation and compliance community at Arcondis
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
- 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
Why Arcondis
- An opportunity to shape the future of healthcare by spearheading transformative deals
- A collaborative and innovative work environment, where your ideas are valued, and your contributions make a significant impact
- Flexible working environment, enabling work-life balance
- Attractive compensation package, inclusive of performance-based incentives that reward exceptional achievements
- Professional growth and development opportunities
