CSV Engineer

Aligned Automation; Indore District; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

Aligned Automation Services Pvt Ltd is seeking an experienced CSV Engineer to drive validation and compliance across pharmaceutical manufacturing. You will ensure GxP-regulated systems are validated, tested, and maintained in line with 21 CFR Part 11, EU Annex 11, and GAMP5 guidelines.

You will lead CSV practices, oversee QA testing, and collaborate with IT, Quality, Manufacturing, and Engineering to ensure audit readiness and regulatory compliance.

Qualifications

• Minimum 5 years of CSV or QA testing in a regulated pharmaceutical or biotech environment.
• Bachelor's degree in CS, Engineering, Life Sciences, or related field.
• Strong knowledge of GxP, 21 CFR Part 11, EU Annex 11, GAMP5, 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.

Responsibilities

• 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 to meet audit and inspection readiness standards.
• 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.

Skills

QA testing

GxP compliance

Documentation

Leadership

Education

Bachelor's degree in Computer Science, Engineering, Life Sciences, or related field

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:

• Bachelorsdegree 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.