CSV Engineer

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