IT GxP Validation Engineer/Lead (4–10 Years Experience, Immediate Joiner Only)

Archimedis Digital; Chennai District; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Archimedis Digital is looking for an experienced IT GxP Validation Lead/Engineer in Chennai, India. The ideal candidate will have 3–5 years of experience in IT Computer System Validation (CSV) with expertise in SDLC and STLC methodologies. Key responsibilities include performing end-to-end validation activities, preparing validation deliverables, and ensuring compliance with GxP requirements. Strong communication and analytical skills are essential for collaboration with cross-functional teams, contributing to a detail-oriented and quality-focused environment.

Qualifications

• 3–5 years of experience in IT Computer System Validation (CSV).
• Strong knowledge of SDLC, STLC and testing methodologies.
• Hands-on experience in Manual and Automation Testing, ETL Testing, and SQL.

Responsibilities

• Perform end-to-end Computer System Validation (CSV) activities.
• Prepare validation deliverables including VSR and Test Protocols.
• Ensure compliance with GxP and regulatory requirements.

Skills

IT Computer System Validation (CSV)

SDLC (Software Development Life Cycle)

STLC (Software Testing Life Cycle)

Agile methodologies

Waterfall model

Manual Testing

Automation Testing

ETL Testing

SQL (query writing, data validation)

HP ALM / similar test management tools

Job description

Archimedis Digital is a global IT services company dedicated to building innovative digital products and solutions for Life Sciences organizations. Through deep expertise in both IT and Life Sciences, we collaborate with clients to address complex business challenges and drive growth across the digital lifecycle. Our services simplify digital transformation while supporting the evolving needs of the industry. We are committed to delivering meaningful impact through our specialized and solution-oriented approach.

Job Title: IT GxP Validation Lead/Engineer

Job Summary

We are seeking an experienced IT Computer System Validation (CSV) Specialist with 3–10 years of relevant experience in regulated environments. The ideal candidate will have strong expertise in validation processes, testing methodologies, and documentation aligned with compliance standards. This role requires hands‑on experience across the software development lifecycle, along with strong communication and stakeholder management skills.

Key Responsibilities

• Perform end-to-end Computer System Validation (CSV) activities for IT systems.
• Prepare and manage validation deliverables including:
• GxP Assessment
• Validation Summary Report (VSR)
• Test Protocols and Reports
• Execute and support functional and system testing activities.
• Ensure compliance with GxP and regulatory requirements.
• Work closely with cross‑functional teams including QA, IT, and business stakeholders.
• Maintain and manage validation artifacts using tools such as HP ALM.
• Support audit readiness and address audit observations.

Required Skills & Experience

• 3–5 years of experience in IT Computer System Validation (CSV).
• Strong knowledge of:
• SDLC (Software Development Life Cycle)
• STLC (Software Testing Life Cycle)
• Methodologies: Agile, Waterfall, V-Model
• Hands‑on experience in:
• Manual and Automation Testing
• ETL Testing
• SQL (query writing, data validation)
• Exposure to GenAI testing is an added advantage.
• Experience with HP ALM / similar test management tools.
• Good understanding of testing frameworks and validation processes.

Soft Skills

• Excellent communication and documentation skills.
• Ability to work collaboratively in cross‑functional teams.
• Strong analytical and problem‑solving abilities.
• Detail‑oriented with a focus on quality and compliance.