CSV Engineer

Aligned Automation Services Pvt Ltd; Pune District; On-site; INR 1,400,000 - 2,100,000; Full time

Job summary

Aligned Automation Services Pvt Ltd in Indore is seeking an experienced CSV Engineer to drive validation and compliance for computerized systems in pharmaceutical manufacturing. You will lead QA testing, oversee validation activities, and ensure adherence to 21 CFR Part 11, EU Annex 11, and GAMP 5 standards.

You will collaborate with IT, Quality, Manufacturing and Engineering teams to implement robust validation strategies, mentor staff, and maintain audit readiness across projects.

Qualifications

• Bachelor's degree in CS/engineering/life sciences or equivalent.
• At least 5 years in Computer Systems Validation (CSV) or QA testing.
• GxP, 21 CFR Part 11, EU Annex 11, GAMP 5, and data integrity knowledge.
• Experience leading validation and QA testing teams.
• Strong documentation, analytical and communication skills.

Responsibilities

• Review and approve validation deliverables and documentation for GxP systems.
• Lead development and execution of validation test plans and scripts.
• Provide QA testing leadership including defect tracking and traceability.
• Ensure compliance plans, URS, traceability matrices, and summary reports are approved.
• Maintain audit readiness and robust testing practices across projects.
• Collaborate with IT, QA, Manufacturing and Engineering to deliver compliant systems.

Skills

CSV

QA Testing

GxP Knowledge

Documentation

Leadership

Communication

Education

Bachelor’s degree in Computer Science/Engineering/Life Sciences

Job description

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