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

📌 CSV Engineer (Pune)
🏢 Important Company of the Sector
📍 Pune