Computer System Validation (CSV) Consultant

Overview

We are looking for an experienced Consultant in Computer System Validation and IT Compliance to lead CSV efforts for our life sciences client. We are hiring dedicated resources to work on a specific client account, where you’ll be involved in ongoing projects and support activities that are critical to the client’s success. This is not just a project-based role — it’s a chance to build deep domain expertise, long-term collaboration, and a meaningful career path.

You will ensure compliance with regulations like 21 CFR Part 11 and Part 820 by developing lifecycle documentation, test protocols, and reviewing technical documentation. Collaborating with customers’ IT, Quality, and Regulatory teams (QA eCompliance, Data Privacy), you will validate both new and existing systems while leveraging best practices in CSV, automation testing, and methodologies such as DevOps, Agile, Scrum, Waterfall, and ITIL.

Note : We are seeking candidates who are currently based in Malaysia and possess a valid work visa. Kindly be aware that we do not offer visa assistance for applicants residing outside the Malaysia region.

Key Responsibilities

• Lead and oversee computer system validation (CSV) efforts for life sciences clients, ensuring adherence to regulatory requirements such as 21 CFR Part 11 and 21 CFR Part 820, but not limited.
• Develop and implement comprehensive lifecycle documentation for GxP relevant computer systems, including the creation and execution of test protocols.
• Review technical documentation and support IT compliance strategies to maintain the security, reliability, and regulatory compliance of computer systems.
• Collaborate with cross-functional teams, including IT, Quality, and Regulatory, to design and execute validation plans for both new and existing computer systems and digital initiatives.
• Provide expert guidance and support on CSV and automation testing, ensuring best practices and regulatory compliance.
• Experienced in DevOps, Agile, Scrum, Waterfall, and ITIL methodologies, with a strong understanding of industry best practices.

Qualifications, Skills and Experience

Why Arcondis

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