CSV Engineer

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 environment.
  
• 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