Job Title: Computer System Validation (CSV) Engineer – Pharmaceutical Manufacturing

Location: Indore

Job Type: Full-time

About the Role:

We are seeking an experienced CSV Engineer to drive the validation and compliance strategy for computerized systems across the pharmaceutical manufacturing area. This role will be responsible for ensuring all GxP-regulated systems are validated, tested, and maintained in compliance with industry regulations including 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines.

This role combines leadership in CSV practices with hands-on Quality Assurance testing oversight, working closely with cross-functional teams across IT, Quality, Manufacturing, and Engineering.

Key Responsibilities:

Validation Leadership & QA Testing

- Review and approve SDLC deliverables and validation documentation for GxP-regulated computerized systems.

- Oversee the development and execution of validation test plans and test scripts for system implementations and changes.

- Provide Quality Assurance leadership in testing activities, including defect tracking, resolution, retesting, and ensuring complete traceability.

- Review and approve compliance plans, user requirements, traceability matrices, and validation summary reports.

- Ensure proper documentation and rigorous testing practices are followed to meet audit and inspection readiness standards.

Compliance & Risk Management

- Maintain current knowledge of applicable regulations (21 CFR Part 11, GAMP, ALCOA+, Data Integrity).

- Ensure validation efforts align with quality and compliance standards to minimize regulatory risk.

- Participate in audits and inspections; review and approve CAPA plans related to audit findings.

- Own,



maintain, and revise CSV-related SOPs, policies, and work instructions.

Team & Project Leadership

- Lead and mentor a team of CSV and QA professionals across various validation projects and system lifecycles.

- Provide strategic CSV support for process improvements, site projects, and system upgrades.

- Collaborate with senior stakeholders to ensure business needs align with validation and compliance expectations.

Stakeholder & Cross-Functional Engagement

- Work closely with project managers, system owners, IT, and QA teams to deliver compliant and efficient systems.

- Serve as the subject matter expert for validation throughout the SDLC and post-implementation phases.

Qualifications:

- Bachelor’s degree in Computer Science, Engineering, Life Sciences, or related field (or equivalent experience).

- Minimum 5 years of experience in Computer Systems Validation (CSV) or QA Testing in a regulated pharmaceutical or biotech workplace.

- Strong knowledge of GxP, 21 CFR Part 11, EU Annex 11, GAMP 5, and Data Integrity principles.

- Demonstrated expertise in QA testing, including test case creation, test execution, and defect resolution.

- Experience validating GxP-related systems.

- Experience leading validation and QA testing teams.

- Excellent analytical, documentation, and communication skills.

Preferred Qualifications:

- Exposure to cloud/SaaS-based GxP system validation.

- Certifications such as PMP, ASQ, or GxP/CSV-related credentials.

Key Competencies:

- Risk-Based Thinking

- Attention to Detail

- Leadership and Coaching

- Quality and Regulatory Focus

- Stakeholder Management

- Problem Solving and Decision Making

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