Computer System Validation Engineer

Chennai, India

Indian Time shift (Some overlap to US time)

​Key Responsibilities

• Requirements Gathering & Analysis: Collaborate with IT, Quality, and business stakeholders to elicit, analyze, translate, and document business requirements into functional and technical specifications.

• Preparation and Execution of Validation Deliverables as per GAMP5 and 21 CFR Part 11 requirements.

• Perform validation activities of Computerized Systems in the Life Sciences/Pharma Industry.

• System Implementation & Support: Work with business users to configure systems, resolve bugs, and implement enhancements.

• SOP Development: Draft and update SOPs, templates, and operational documentation to align with regulatory standards.

• System Administration: Manage user access provisioning, security roles, and configuration management for supported systems.

• Stakeholder Engagement: Partner with global teams to ensure timely project delivery, meeting regulatory compliance standards (e.g., CFR Part 11).

• Training & Manuals:



Develop user manuals and provide training to ensure effective system usage by the business community.

Requirements
• Minimum 3 years in IT and/or R&D; and Quality operations within the biotech or life sciences industry.

• 5+ years of experience implementing solutions for quality, clinical operations, and regulatory affairs.

• Hands-on experience with Veeva Vault, Benchling, or similar platforms is required.

• Knowledge of clinical trial management, regulatory operations, and Computer Systems Validation (CSV).

• Familiarity with Software Development Life Cycle (SDLC) policies in regulated environments.

• Education:

• Bachelor’s degree in Computer Science, Pharmaceutical Science, Biochemistry, Chemistry, or related fields is required.

• Master’s degree preferred.

Technical Skills:

• Demonstrated expertise in writing software requirements, test specifications, and validation protocols.

• Proficiency in managing g

📌 Computer System Validation Engineer (Chennai)
🏢 Pharmatek Consulting
📍 Chennai