Cleanstep Pharma And Engineering Solutions
CSV Validation Engineer
Skills
2 months ago
Share this opportunity
Share this opportunity to other talents of your network:
✓ Offer them a visibility boost with clients.
✓ Help your contacts find their next job.
Important information
Contract type:
Permanent
Salary:
₹350,000 – ₹850,000 / year
Location:
Chennai, Tamil Nadu, India
Work mode:
Onsite
Published on:
12 August 2026
What they need
Roles and Responsibilities
Conduct CSV activities such as Risk assessment, Gap analysis, and validation planning.
Perform computer system validation (CSV) activities according to industry standards like GAMP5 and 21 CFR Part 11.
Ensure compliance with EU Annexure 11 requirements for software validation.
Collaborate with cross-functional teams to identify and resolve issues related to HPLC, LIMS, EMS, BMS systems.
Develop test scripts and execute tests using V-model approach.
Preparation, Execution, Compilation and approval of below documents (Not limited to)
- User requirement specifications
- Validation Plan
- GxP Assessment
- System Design Specification
- Risk Assessment
- Network (Infra) Qualification
- Installation Qualification protocol
- Operational Qualification
- Performance Qualification
- Traceability matrix
- Validation summary report
Other offers great for you!
These companies are also looking for great profiles
LeHibou
SAP S/4HANA CSV & Validation Consultant
675€ / jour
Freelance
55 Mainz, Germany
Hybrid
Skills
12 days ago
Quick apply
Fakto
AI Software Engineer
€70k–€90k
Permanent contract
Paris, France
Hybrid
Skills
12 hours ago
Quick apply
Kalytech Consulting
Automation Engineer
540€
Freelance
Leuven, Belgium
Hybrid
Skills
8 hours ago
Quick apply