Designation: CSV & Software Validation Lead / Specialist

Preferred Experience: 3+ Years

Job Summary

Aventior is seeking a CSV & Software Validation Specialist with experience in the biopharmaceutical, pharmaceutical, biotechnology, or life sciences industry. The ideal candidate will have a strong understanding of regulatory compliance, quality management, computerized system validation (CSV), and software testing within regulated environments.

The role involves ensuring that software applications and computerized systems meet applicable regulatory requirements, quality standards, and business specifications. The candidate will be responsible for developing and executing test cases, validating system functionality, documenting test results, managing defects, and supporting compliance activities in accordance with GxP, FDA 21 CFR Part 11, GAMP 5, and other relevant regulatory frameworks.

The candidate will collaborate with Quality Assurance, Software Development, Clinical Operations, IT, and Regulatory Affairs teams to ensure software quality, data integrity, and regulatory compliance throughout the software development and validation lifecycle.

Key Responsibilities

1. Regulatory Compliance & Quality Assurance

- Ensure adherence to applicable GxP requirements, including GMP, GCP, and GLP, based on project and system requirements.
- Support compliance with FDA 21 CFR Part 11, EU and UK regulations for electronic records, electronic signatures, audit trails, and access controls.
- Apply GAMP 5 principles and risk-based approaches to computerized system validation and software testing.
- Review and maintain SOPs, work instructions, validation documents, and quality records.
- Support compliance assessments, internal and external audits, client audits, and regulatory inspection readiness.
- Assist with deviation management, CAPA, change control, risk assessments, and compliance remediation activities.
- Support data integrity, security, traceability, and documentation requirements for regulated systems.

2. Software Testing & Quality Engineering

- Review business requirements, functional specifications, and technical documentation to identify test scenarios and acceptance criteria.
- Prepare and execute test plans, test cases, test scripts, and test scenarios for software applications used in biopharma and life sciences.
- Perform functional, integration, regression, system, and user acceptance testing (UAT), as applicable.
- Validate application workflows, data processing, user permissions, audit trails, electronic signatures, and system interfaces.
- Identify, document, track, and retest software defects in collaboration with development and QA teams.
- Maintain requirements traceability matrices (RTMs) to establish traceability between requirements, risks, test cases,



and test results.
- Ensure testing activities are documented, reproducible, and aligned with approved procedures and validation protocols.
- Support test execution, defect triage, root-cause analysis, and resolution verification.
- Participate in release testing, regression testing, and post-implementation verification.

3. Computerized System Validation (CSV)

- Support validation activities for GxP-regulated software applications and computerized systems.
- Prepare and maintain validation lifecycle documentation, including User Requirements Specifications (URS), risk assessments, validation plans, and test protocols.
- Execute or support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), where applicable.
- Assist with validation of recent systems, system upgrades, configuration changes, integrations, and software releases.
- Ensure validation evidence is complete, accurate, approved, and audit-ready.
- Support periodic reviews, change impact assessments, and revalidation activities based on risk and regulatory requirements.
- Apply risk-based validation principles in accordance with GAMP 5 and organizational quality procedures.

4. Biopharma & Life Sciences Application Testing

- Test and validate applications supporting clinical trials, clinical data management, pharmaceutical quality processes, laboratory operations, and regulatory workflows.
- Understand regulated-system requirements relating to patient data, clinical trial records, laboratory data, and electronic documentation.
- Verify data accuracy, completeness, consistency, access controls, audit trails, and system-generated records.
- Support testing of integrations between clinical, laboratory, quality management, and other enterprise applications.
- Help ensure that software changes do not compromise patient safety, product quality, data integrity, or regulatory compliance.
- Support HIPAA-related privacy and security requirements when applications handle protected health information (PHI).

Required Skills & Qualifications

- Bachelor's degree in Life Sciences, Biotechnology, Pharmacy, Computer Science, Information Technology, Quality Management, or a related discipline.
- Minimum 3 years of relevant experience in compliance, software testing, quality assurance, or computerized system validation within pharmaceutical, biotechnology, clinical research,



or life sciences environments.
- Strong understanding of GxP regulations, including GMP, GCP, and GLP.
- Working knowledge of FDA 21 CFR Part 11, GAMP 5, EU and UK regulations, and electronic records and electronic signature requirements.
- Hands-on experience in manual software testing, test case preparation, test execution, defect tracking, and regression testing.
- Hands on experience with QMS platforms like ServiceNow, Veeva, Master Control a huge plus.
- Experience preparing or executing validation protocols and maintaining validation documentation, including URS, IQ, OQ, PQ, and RTMs, as applicable.
- Knowledge of SDLC, STLC, requirements traceability, risk-based testing, and change management.
- Experience with CAPA, deviation management, change control, and audit documentation.
- Understanding of data integrity, audit trails, access controls, and security requirements in regulated systems.
- Strong analytical, documentation, communication, and problem-solving skills.
- Ability to work collaboratively with cross-functional teams and manage multiple testing and compliance activities.

Company Overview:

Aventior is a leading provider of innovative, end-to-end technology solutions, empowering businesses across diverse industries to solve complex challenges and accelerate growth. We harness the power of cutting-edge technologies such as artificial intelligence (AI), machine learning (ML), MLOps, and DevOps to build scalable, future-ready solutions that drive measurable business outcomes for the life science industry.

Our expertise extends across the entire data lifecycle. We offer comprehensive data development and management services, including cloud data architecture, universal data models, Data Transformation & ETL, data lakes, user management, Analytics & visualization, and automated data capture for unstructured and semi-structured sources such as scanned documents. These capabilities enable organizations to unlock the full value of their data and make faster, more informed decisions.

At Aventior, our strength lies in combining deep industry expertise with advanced technical capabilities. Our teams work closely with clients to design and deliver tailored solutions that align with their unique business needs—whether it’s optimizing operations, enhancing customer experiences, or driving strategic decision-making.

We bring a holistic, cross-industry perspective to every engagement, supported by a strong foundation in design, implementation, innovation, migration, and ongoing support. With a global delivery model, a multi-country presence, and a team of highly skilled professionals, Aventior is well-positioned to deliver consistent, high-quality outcomes at scale.

📌 CSV & Software Validation Lead / Specialist (Pune)
🏢 Aventior
📍 Pune