Atomic Recruitment SEA Hiring! Full Time CSV Engineer (Pharma) (Based in Shenzen) in Federal Territory - Ricebowl

Job Title: CSV Engineer

Employment Type: Full-Time (Visa Application Provided)

About the Role

We are looking for an experienced IT Compliance Engineer to oversee the validation and compliance of computerized systems within a regulated manufacturing environment. In this role, you will ensure business applications, infrastructure, and digital systems meet GxP standards and global regulatory requirements while supporting system integrity, data quality, and operational compliance.

Key Responsibilities

• Develop and maintain validation strategies for computerized systems, software applications, and supporting infrastructure in line with global regulatory standards (FDA, EMA, NMPA, etc.).
• Prepare, review, and maintain validation deliverables, including validation plans, protocols, risk assessments, test documentation, and final reports.
• Plan and execute system qualification activities, including Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and periodic revalidation where required.
• Support change management by evaluating system modifications, assessing compliance impact, and updating validation records accordingly.
• Perform risk assessments to identify potential compliance, data integrity, and operational risks, while recommending appropriate mitigation measures.
• Partner closely with Quality, Engineering, Manufacturing, and IT teams to ensure validation activities align with quality management systems and regulatory expectations.
• Provide guidance and training on CSV methodologies, compliance requirements, and industry best practices to internal stakeholders.
• Drive continuous improvement initiatives to enhance validation processes, documentation standards, and overall compliance efficiency.
• Keep up to date with evolving industry regulations, validation methodologies, and compliance expectations.

Requirements

• Bachelor's Degree in Computer Science, Information Technology, Engineering, or a related discipline.
• At least 5 years of experience in Computerized Systems Validation (CSV), IT Compliance, or a similar regulated environment.
• Good understanding of GxP requirements and international regulatory standards such as FDA, EMA, and related guidelines.
• Hands-on experience conducting IQ, OQ, PQ, and validation lifecycle activities for computerized systems.
• Familiarity with IT infrastructure, software development lifecycle (SDLC), and system implementation processes.
• Strong analytical thinking, troubleshooting, and problem-solving abilities.
• High level of accuracy with excellent documentation skills.
• Effective communication skills with the ability to collaborate across multiple functions.
• Able to work independently as well as within cross-functional teams.

Preferred Experience

• Professional certification in Computerized Systems Validation (CSV), Quality, or a related discipline.
• Previous experience within the pharmaceutical, medical device, biotechnology, or life sciences industry would be an advantage.