Validation Expert

ARCONDIS AG / GmbH; Malaysia; On-site; MYR 80,000 - 110,000; Full time

Job summary

ARCONDIS AG / GmbH is seeking a Consultant Digitalization of Customer Engagement in Malaysia. The role focuses on ensuring the compliant operation of GxP computer systems, leading validation efforts, and supporting compliance with regulations.

Ideal candidates will have a Bachelor’s degree and over 5 years of experience in IT compliance. Familiarity with FDA regulations and experience with validated systems are essential. Flexibility in hours and willingness to travel are required.

Qualifications

• 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.
• Willing to travel up to 20% based on project needs.

Responsibilities

• Ensure continuous, compliant operation of GxP-relevant computer systems.
• Lead and coordinate validation and re-validation efforts with documentation.
• Support change management and compliance aligned with regulations.

Skills

GxP computer systems operation

Validation efforts coordination

Compliance support

Stakeholder collaboration

FDA regulations knowledge

Education

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

Master’s degree (preferred)

Tools

SAP

CTMS

Veeva Vault

MES

LIMS

eLN

Job description

Consultant Digitalization of Customer Engagement (Life Sciences)

Tasks and 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.
• Candidates must be willing and able to work according to Central European Time (CET) business hours.

Qualifications

• 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.