Experience: 3-8 years
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
