Validation Expert

Arcondis Group; Kuala Lumpur; Vor Ort; MYR 90.000 - 130.000; Vollzeit

Zusammenfassung

Arcondis Group seeks a Validation Expert to maintain validated state of GxP-relevant computer systems within long-term Managed Services engagements. You will coordinate validation activities for global clients and ensure audit-ready lifecycle documentation.

You will apply regulatory best practices, support changes and migrations while preserving validation. Collaboration with IT, Quality and Regulatory teams is essential, and knowledge of ITIL, Agile, DevOps is required.

Qualifikationen

• Bachelor's degree in Computer Science, Engineering or Life Sciences.
• 5+ years in computer system validation or IT compliance in pharma/medical tech.
• Strong knowledge of FDA 21 CFR Part 11, Part 820, GAMP 5.
• Experience with validated platforms (SAP, CTMS, Veeva Vault, MES, LIMS, ELN).

Aufgaben

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

Kenntnisse

Documentation

Stakeholder collaboration

Service orientation

Travel readiness

Ausbildung

Bachelors in CS/Engineering/Life Sciences

Tools

SAP

CTMS

Veeva Vault

MES

LIMS

ELN

ITIL tools

Jobbeschreibung

Requisition #

Job Title

Validation Expert

Contract Type

Full Time

Category

Managed Services

Location

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 5years 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.