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, s

📌 CSV Engineer (India)
🏢 Aligned Automation Services
📍 India