Digital Office
Senior CSV / CSA Validation Consultant
-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
1
-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
841
Kosice, Malaysia, Frankfurt, Boston
Digital Office
-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
1
-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
841
Kosice, Malaysia, Frankfurt, Boston