CSV Engineer

About the Job

About
Aligned Automation

At
Aligned Automation, we live by our "Better
Together" philosophy to build a better world. As a strategic service
provider to Fortune 500 companies, we help digitize enterprise operations and
drive impactful business strategies. Our purpose goes beyond projects—we strive
to deliver meaningful, sustainable change that shapes a more optimistic and
equitable future.

Our
culture is deeply rooted in our 4Cs—Care, Courage, Curiosity,
and Collaboration—ensuring that each employee is empowered to grow,
innovate, and thrive in an inclusive workplace.

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 life -cycles.
  
• 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