全职 Validation Expert 工作, 薪水, Arcondis Group Federal Territory 公司招聘中 - Ricebowl

Overview

The Validation Expert maintains the validated state of GxP-relevant computer systems within long-term Managed Services engagements. Working with global clients, the role applies regulatory best practices, coordinates validation activities and supports continuous improvement within a structured service-delivery model.

Key Responsibilities

• Maintain the continuous and compliant operation of GxP-relevant computer systems within Managed Services.
• Lead and coordinate validation and revalidation activities and maintain audit-ready lifecycle documentation.
• Support changes, upgrades, migrations and decommissioning while preserving the validated state of systems.
• Provide compliance support aligned with 21 CFR Part 11, 21 CFR Part 820, EudraLex and GAMP 5.
• Collaborate with client IT, Quality and Regulatory teams on validation and compliance actions.
• Standardise and reuse validation templates, protocols and procedures across systems and clients.
• Monitor regulatory developments and adapt validation strategies where required.
• Integrate validation activities with incident management, CAPA and change-control processes.
• Work within ITIL, Agile, DevOps and Waterfall delivery approaches.
  
  

Requirements

Qualifications

• Bachelor’s degree in Computer Science, Engineering or Life Sciences.
  
  

Skills

• Strong documentation, communication and stakeholder-collaboration skills.
• Service-oriented approach and motivation to support improved healthcare outcomes.
• Flexibility in working hours based on project needs.
• Willingness to travel up to 20%.
  
  

Experience and Knowledge

• At least 5 years of experience in Computer System Validation, IT compliance or quality assurance.
• Strong knowledge of FDA 21 CFR Part 11 and Part 820, GAMP 5 and quality management systems in pharmaceutical or medical technology environments.
• Experience with validated platforms such as SAP, CTMS, Veeva Vault, MES, LIMS and electronic laboratory notebooks.
• Familiarity with ITIL-based service operations and testing-automation tools.
  
  

Advantageous

• Master’s degree in Computer Science, Engineering, Life Sciences or a related field.