We are seeking a highly skilled and self-driven GxP Validation Engineer with 4 to 8 years of experience to drive computer system validation (CSV) and testing activities for enterprise-level life sciences systems. The ideal candidate should have extensive hands-on experience across the validation lifecycle—covering documentation, testing, and risk-based validation—aligned with Agile, Waterfall, and V-Model methodologies
You will be responsible for ensuring compliance with global GxP, 21 CFR Part 11, and data integrity principles, while effectively consulting with cross-functional teams to deliver high-quality validation deliverables
Key Responsibilities:
- Lead and execute end-to-end validation activities for enterprise-level GxP-regulated systems (R&D, PV, Quality, Manufacturing, or Commercial)
- Develop, review, and approve validation deliverables including Validation Plan, Risk Assessment, Test Strategy, Protocols (IQ/OQ/PQ), Traceability Matrix, and Summary Reports
- Perform hands-on test design, execution, and defect management using tools such as HP ALM, Jira-Xray, or Matrix ALM (or equivalent)
- Apply CSA (Computer Software Assurance) principles for risk-based and efficient validation approaches
- Collaborate closely with IT, QA, Business, and vendor teams to ensure regulatory compliance and smooth delivery
- Drive validation efforts in Agile and hybrid environments, aligning sprint deliverables with validation needs
- Ensure adherence to 21 CFR Part 11, Annex 11, and Data Integrity requirements
- Provide consulting and guidance on validation strategy, tool qualification, and process optimization
- Leverage knowledge in industry-standard platforms such as Veeva Vault Suite, Pharmacovigilance (PV) systems, R&D systems, and LIMS
- Demonstrate strong understanding and practical application of Gen AI testing and validation of AI-enabled systems in a regulated context
- Mentor junior validation team members and contribute to continuous process improvement
Required Skills & Experience:
- 4–8 years of relevant experience in GxP validation and testing within life sciences or pharmaceutical domains
- Strong knowledge of Agile, Waterfall, and V-Model methodologies
- Hands-on expertise with HP ALM, Jira-Xray, Matrix ALM, or similar test management tools
- Proven track record of leading end-to-end validation for enterprise-level systems
- Solid experience with Veeva Suite (Vault QMS, RIM, QualityDocs, etc.), PV, and R&D platforms
- Strong understanding of CSV, CSA, Data Integrity, and 21 CFR Part 11/Annex 11 compliance
- Practical exposure to AI/GenAI testing methodologies and regulatory expectations for AI-based systems
- Excellent communication, stakeholder management, and consulting skills
- Ability to work independently and take ownership of project deliverables
Job Location: Guindy, Chennai
Pay: From ₹350,000.00 per year
Benefits:
- Flexible schedule
- Health insurance
- Paid sick time
- Paid time off
- Provident Fund
- Work from home
Ability to commute/relocate:
- Chennai, Tamil Nadu: Reliably commute or planning to relocate before starting work (Preferred)
Application Question(s):
- What is your current CTC? "________"
- What is your expected CTC? "_________"
Work Location: In person
