CSV Lead

Job Description

Zensar is seeking an experienced Computer System Validation (CSV) Expert to join its Hleathcare and Life Sciences team. This is a senior role responsible for leading the validation of GxP-regulated computerised systems, including infrastructure, clinical, and business systems.

The successful candidate will bring deep hands-on experience in CSV lifecycle activities, a thorough understanding of applicable regulations and guidance (21 CFR Part 11, EU Annex 11, GAMP5 2nd Ed.), and the ability to operate independently in a fast-paced, regulated environment. You will serve as the subject matter expert for CSV matters, partnering closely with IT, QA, and business stakeholders.

Responsibilities

Key Responsibilities

Validation Lifecycle Management

• Lead end-to-end CSV activities for GxP computerised systems including infrastructure (servers, cloud platforms), laboratory systems (LIMS, ELN), clinical systems, and enterprise applications (ERP, QMS, EDMS).
• Author, review, and approve validation lifecycle documents and Configuration Specifications including Validation Plans, URS, FRS, SDS, IQ/OQ/PQ protocols, Traceability Matrices, and Validation Summary Reports.
• Define and enforce validation strategies based on GAMP5 system categorisation (Category 3, 4, and 5) and risk-based approaches per ICH Q9.
• Ensure all validation documentation meets 21 CFR Part 11 and EU Annex 11 requirements and is maintained in a validated state throughout the system lifecycle.
• Manage periodic review and revalidation activities in accordance with EU Annex 11 Clause 11 and internal procedures.
• Assess the GxP impact of infrastructure changes: OS patches, cloud migrations, network configuration updates, and determine re-qualification requirements.
  
  

Regulatory Compliance & Audit Readiness

• Serve as the primary CSV subject matter expert during FDA inspections, EU GMP audits, and internal quality audits.
• Maintain a validated systems inventory and ensure all GxP systems have current, approved validation documentation.
• Conduct gap assessments of existing SOPs, validation packages, and system configurations against 21 CFR Part 11, EU Annex 11, and GAMP5 requirements.
• Ensure audit trail requirements are defined, implemented, and reviewed per 21 CFR Part 11.10(e) and EU Annex 11 Clause 9.
  
  

Change Control & Deviation Management

• Assess change requests for GxP impact and determine validation implications, including re-qualification triggers for changes to validated systems.
• Author and review Change Control records for GxP-regulated systems in accordance with EU Annex 11 Clause 10 and internal change management SOPs.
• Manage deviation and CAPA processes for CSV-related incidents, ensuring timely root cause analysis and corrective action closure.
  
  

Stakeholder Partnership & Governance

• Partner with IT, QA, Regulatory Affairs, and business system owners to ensure validated systems meet both operational and compliance requirements.
• Provide CSV guidance and training to IT administrators, business system owners, and QA personnel on validation obligations and procedures.
• Maintain and improve CSV SOPs, templates, and procedural frameworks in alignment with current regulatory expectations.
• Support supplier qualification activities including vendor audits, supplier assessments, and review of supplier-provided validation documentation.
  
  

Qualifications

Required Skills & Competencies

• 8–10 years of hands-on CSV experience in a regulated Life Sciences environment.
• Deep working knowledge of 21 CFR Part 11, EU Annex 11, GAMP5 (2nd Edition), ICH Q9 (R1), ICH Q10, etc.
• Demonstrated experience authoring and executing IQ/OQ/PQ protocols, validation plans, and summary reports for a range of system categories.
• Experience validating infrastructure systems, servers, cloud platforms (AWS/Azure), and network components, in a GxP context.
• Proven ability to conduct GxP gap assessments and translate findings into actionable remediation plans.
• Experience managing CSV deliverables through FDA inspections or EU GMP audits with successful outcomes.
• Strong understanding of audit trail requirements, electronic record management, and data integrity principles.
• Proficiency with validated EDMS / QMS platforms (e.g., Veeva Vault, OpenText, MasterControl).
• Bachelor's degree in Life Sciences, Computer Science, Engineering, or a related field.
  
  

About Us

At Zensar, we're experience-led everything. We are committed to conceptualizing, designing, engineering, marketing, and managing digital solutions and experiences for over 130 leading enterprises. We are a company driven by a bold purpose: Together, we shape experiences for better futures. Whether for our clients, our people, or the world around us, this belief powers everything we do. At the heart of our culture is ONE with Client - a set of four core values that reflect who we are and how we work: One Zensar, Nurturing, Empowering, and Client Focus.

Part of the $4.8 billion RPG Group, we're a community of 10,000+ innovators across 30+ global locations, including Milpitas, Seattle, Princeton, Cape Town, London, Zurich, Singapore, and Mexico City. Explore Life at Zensar and join us to Grow. Own. Achieve. Learn. to be the best version of yourself.

We believe the best work happens when individuality is celebrated, growth is encouraged, and well-being is prioritized. We are an equal employment opportunity (EEO) and affirmative action employer, committed to creating an inclusive workplace. All qualified applicants will be considered without regard to race, creed, color, ancestry, religion, sex, national origin, citizenship, age, sexual orientation, gender identity, disability, marital status, family medical leave status, or protected veteran status.