CSV Engineer

Aligned Automation Services; Pune District; On-site; INR 1,500,000 - 2,500,000; Full time

Job summary

Aligned Automation Services Pvt Ltd seeks an experienced CSV Engineer to drive validation and compliance strategy for computerized systems in pharmaceutical manufacturing. You will lead QA testing across IT, Quality, Manufacturing, and Engineering, ensuring 21 CFR Part 11 and EU Annex 11 compliance.

The role combines leadership in CSV practices with hands-on testing oversight, mentoring a team of CSV and QA professionals while maintaining audit readiness and regulatory compliance across complex

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, GAMP5, and Data Integrity.
• 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.

Responsibilities

• Review and approve SDLC deliverables and validation documentation for GxP-regulated systems.
• Oversee the development and execution of validation test plans and scripts for system implementations and changes.
• Provide QA testing leadership in activities including defect tracking, resolution, retesting, and traceability.
• Review and approve compliance plans, user requirements, traceability matrices, and validation summary reports.
• Ensure rigorous documentation and testing practices to meet audit and inspection standards.
• Lead and mentor a team of CSV and QA professionals across validation projects and lifecycles.
• Provide strategic CSV support for process improvements, site projects, and system upgrades.
• Collaborate with senior stakeholders to align business needs with validation and compliance.

Skills

CSV

QA Testing

GxP

21 CFR Part 11

EU Annex 11

GAMP5

Data Integrity

Test Case Creation

Defect Resolution

Team Leadership

Education

Bachelor's degree in CS/Engineering/Life Sciences

Job description

Aligned Automation Services Pvt Ltd | Full time

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

Job Type: Full-time

About the Role:

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

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

Key Responsibilities:

• Reviewand approve SDLC deliverables and validation documentation forGxP-regulated computerized systems.
  
• Overseethe development and execution of validation test plans and test scriptsfor system implementations and changes.
  
• ProvideQuality Assurance leadership in testing activities, including defecttracking, resolution, retesting, and ensuring complete traceability.
  
• Reviewand approve compliance plans, user requirements, traceability matrices,and validation summary reports.
  
• Ensureproper documentation and rigorous testing practices are followed to meetaudit and inspection readiness standards.
  

Compliance & Risk Management

• Maintaincurrent knowledge of applicable regulations (21 CFR Part 11, GAMP, ALCOA+,Data Integrity).
  
• Ensurevalidation efforts align with quality and compliance standards to minimizeregulatory risk.
  
• Participatein audits and inspections; review and approve CAPA plans related to auditfindings.
  
• Own,maintain, and revise CSV-related SOPs, policies, and work instructions.
  
• Leadand mentor a team of CSV and QA professionals across various validationprojects and system lifecycles.
  
• Providestrategic CSV support for process improvements, site projects, and systemupgrades.
  
• Collaboratewith senior stakeholders to ensure business needs align with validationand compliance expectations.
  

Stakeholder & Cross-FunctionalEngagement

• Workclosely with project managers, system owners, IT, and QA teams to delivercompliant and efficient systems.
  
• Serveas the subject matter expert for validation throughout the SDLC andpost-implementation phases.
  

Qualifications:

• Bachelor’sdegree in Computer Science, Engineering, Life Sciences, or related field(or equivalent experience).
  
• Minimum5 years of experience in Computer SystemsValidation (CSV) or QA Testing in a regulated pharmaceutical orbiotech environment.
  
• Strongknowledge of GxP, 21 CFR Part 11, EU Annex 11, GAMP5, and Data Integrity principles.
  
• Demonstratedexpertise in QA testing, including test case creation, testexecution, and defect resolution.
  
• Experiencevalidating GxP-related systems.
  
• Experienceleading validation and QA testing teams.
  
• Excellentanalytical, documentation, and communication skills.
  

Preferred Qualifications:

• Exposureto cloud/SaaS-based GxP system validation.
  
• Certificationssuch as PMP, ASQ, or GxP/CSV-related credentials.