Senior CSV Engineer

Key Responsibilities

- Lead and execute end-to-end Computer System Validation (CSV) lifecycle activities for SAP implementations, upgrades, support packs, patches, and change controls.
- Develop, review, and approve critical validation deliverables, including Validation Master Plans (VMP), User Requirement Specifications (URS), and Validation Summary Reports (VSR).
- Author, execute, and review Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
- Apply GAMP 5 risk-based approaches to categorize SAP systems, evaluate functional risks, and determine appropriate validation scope and depth.
- Collaborate with SAP functional and technical teams to understand system design and translate business requirements into validation criteria.
- Conduct change impact assessments for system changes, patches, and enhancements to define re-validation needs.
- Ensure compliance with global regulatory standards and internal quality policies, including 21 CFR Part 11 and EU Annex 11.
- Provide expert advice on validation best practices and regulatory compliance to cross-functional teams.

Overview

- The Senior CSV Engineer will be part of our dynamic team in Bangalore, focusing on ensuring compliance and quality within the BFSI sector.
- This role involves leading and executing comprehensive Computer System Validation (CSV) activities for SAP systems in a GxP-regulated pharmaceutical environment.
- As a key player, you will be responsible for implementing end-to-end validation processes, ensuring all SAP upgrades, patches, and change controls adhere to stringent global regulatory standards.
- You will work collaboratively with cross-functional teams to support the seamless integration and validation of SAP systems.
- This position requires a deep understanding of SAP architecture and its application within GxP environments, along with a robust experience in risk-based validation approaches.
- Your expertise will ensure that our systems maintain the highest standards of compliance and operational excellence.
- You will advise and ensure adherence to quality standards, playing a critical role in safeguarding data integrity and regulatory compliance across our SAP implementations.
- This role offers a unique opportunity to lead validation efforts in a fast-paced, regulated environment, ensuring compliance with 21 CFR Part 11, EU Annex 11, and other global standards.

Requirements

- 9 to 12 years of experience in SAP Computer System Validation within a GxP-regulated environment.
- Expert knowledge of global regulatory frameworks such as 21 CFR Part 11, EU Annex 11, and Data Integrity principles (ALCOA+).
- Proven mastery of GAMP 5 guidelines and risk-based validation methodologies.
- Strong understanding of SAP architecture and core modules including QM, MM, PP, WM/EWM, and SD.
- Exceptional technical writing, analytical, and stakeholder management skills.
- Ability to lead complex validation projects and manage cross-functional teams effectively.
- Excellent communication and collaboration skills, with a focus on quality and compliance.