Validation Expert

Arcondis AG seeks a Senior Validation Expert to lead GxP computer system validation within its Managed Services division, ensuring regulatory compliance and operational excellence.

This position sits within the Managed Services team at Arcondis AG. The primary purpose of the role is to oversee the validation of computer systems, ensuring they remain compliant and operate continuously in accordance with industry standards.

Responsibilities

• Direct and coordinate validation and re-validation projects, ensuring all lifecycle documentation is complete and ready for audits.
• Manage change control processes, including system upgrades, migrations, and decommissioning, while maintaining valid states.
• Provide expert guidance on compliance matters related to 21 CFR Part 11, Part 820, EudraLex, and GAMP5.
• Work closely with client IT, Quality, and Regulatory departments to align on validation strategies and compliance actions.
• Develop and standardize validation templates, protocols, and procedures to ensure consistency across different systems and clients.
• Track regulatory changes and adjust validation strategies to maintain compliance.
• Integrate validation activities with service management processes such as incident management, CAPA, and change control.
• Apply delivery methodologies including ITIL, Agile, DevOps, and Waterfall in project execution.

Requirements

• Bachelor’s degree in Computer Science, Engineering, or Life Sciences.
• At least five years of experience in computer system validation, IT compliance, or quality assurance.
• Deep understanding of FDA regulations (21 CFR Part 11, 820), GAMP5, and Quality Management Systems in pharma/MedTech.
• Hands-on experience with validated systems such as SAP, CTMS, Veeva Vault, MES, LIMS, and eLN.
• Familiarity with ITIL-based service operations and testing automation tools.
• Excellent documentation, communication, and stakeholder collaboration skills.
• Willingness to travel up to 20% and flexibility in working hours based on project needs.
• Availability to work during Central European Time (CET) business hours.

Nice to have

• Master’s degree.

About the company

Arcondis AG is a global consulting firm dedicated exclusively to the healthcare and life science sectors. Owned by a charitable Foundation, the company contributes to social causes annually and operates under the motto 'We make healthcare better.' The organization fosters a collaborative, innovative, and inclusive culture where leadership leads by example.

• Exclusive focus on healthcare and life science industries.
• Ownership by a charitable Foundation with annual contributions to social causes.
• Motto: 'We make healthcare better'.
• Culture fostering collaboration, innovation, and community.
• Leadership expected to lead by example, demonstrating dedication to mission and values.
• Commitment to diversity and inclusivity.