Arcondis is a global consulting company with an exclusive focus on the healthcare and life science industries. Headquartered in Basel, Switzerland, the company has a global footprint with offices in North America, APAC and across Europe. We have been managing challenges and solving problems for our clients in compliance, business processes, information technology, and digital transformation since 2001. Our focus lies in creating value through cross-functional, sophisticated delivery methodologies and intelligent implementation. Our clients love to work with us because of our unique skillsets, our pragmatic approach, and our will to win.
We are a medium-sized international consulting firm dedicated to Life Sciences, with a unique and inspiring culture. Our distinctive culture is the driving force behind our success; it is deeply rooted in our purpose and behaviors.
We are owned by a charitable Foundation; our key differentiator is that we contribute to social causes every year. This ethos is not just a part of our identity; it's our way of life. Our motto, "We make healthcare better," reflects the unwavering commitment we have to improving the lives of people through the work we do.
Our culture fosters collaboration, innovation, and a sense of community that sets us apart from the rest. We are living our values every day. Our leadership is expected to lead by example, demonstrating a dedication to our mission and values.
We embrace diversity and inclusivity, and we believe in giving back to the community. Together, we are not just consultants; we are agents of change, and our culture is the driving force behind our shared purpose.
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
Arcondis is a global consulting company with an exclusive focus on the healthcare and life science industries. Headquartered in Basel, Switzerland, the company has a global footprint with offices in North America, APAC and across Europe. We have been managing challenges and solving problems for our clients in compliance, business processes, information technology, and digital transformation since 2001. Our focus lies in creating value through cross-functional, sophisticated delivery methodologies and intelligent implementation. Our clients love to work with us because of our unique skillsets, our pragmatic approach, and our will to win.
We are a medium-sized international consulting firm dedicated to Life Sciences, with a unique and inspiring culture. Our distinctive culture is the driving force behind our success; it is deeply rooted in our purpose and behaviors.
We are owned by a charitable Foundation; our key differentiator is that we contribute to social causes every year. This ethos is not just a part of our identity; it's our way of life. Our motto, "We make healthcare better," reflects the unwavering commitment we have to improving the lives of people through the work we do.
Our culture fosters collaboration, innovation, and a sense of community that sets us apart from the rest. We are living our values every day. Our leadership is expected to lead by example, demonstrating a dedication to our mission and values.
We embrace diversity and inclusivity, and we believe in giving back to the community. Together, we are not just consultants; we are agents of change, and our culture is the driving force behind our shared purpose.
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