Kerja Sepenuh Masa, Validation Expert di Arcondis Group Federal Territory - Maukerja

Job Overview

Are you passionate about ensuring the reliability and compliance of critical IT systems in the life sciences industry? Join our Managed Services team as a Validation Expert, where you’ll play a key role in maintaining the validated state of GxP-relevant systems for long-term service engagements. This position offers the opportunity to work closely with global clients, applying regulatory best practices and driving continuous improvement in a structured service delivery model.

Key Responsibilities

• Ensure continuous, compliant operation of GxP-relevant computer systems under Managed Services.
• Lead and coordinate validation and re-validation efforts, maintaining audit-ready lifecycle documentation.
• Support change management, upgrades, migrations, and decommissioning while preserving validation state.
• Provide ongoing compliance support aligned with 21 CFR Part 11, Part 820, EudraLex, and GAMP5.
• Collaborate with client IT, Quality, and Regulatory teams to align on validation and compliance actions.
• Standardize and reuse validation templates, protocols, and procedures across systems and clients.
• Monitor regulatory developments and adapt validation strategies accordingly.
• Integrate validation with service processes such as incident management, CAPA, and change control.
• Operate within delivery methodologies like ITIL, Agile, DevOps, and Waterfall.

Qualifications, Skills and Experience

• Bachelor’s degree in Computer Science, Engineering, or Life Sciences; Master’s preferred
• 5+ years of experience in computer system validation, IT compliance, or quality assurance
• Strong knowledge of FDA regulations (21 CFR Part 11, 820), GAMP5, and QMS in pharma/MedTech
• Experience with validated systems such as SAP, CTMS, Veeva Vault, MES, LIMS, and eLN
• Familiarity with ITIL-based service operations and testing automation tools
• Strong documentation, communication, and stakeholder collaboration skills
• Motivation to improve global healthcare and deliver exceptional service
• Willingness to travel up to 20% and flexibility in working hours based on project needs

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