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