Csv Validation Engineer

Key Role

1. Develop, write, and maintain compliance and quality-related documents, including:

2. Standard Operating Procedures (SOPs)

3. Work Instructions (WIs)

4. Validation Protocols (IQ/OQ/PQ)

5. Risk Assessments

6. Quality Manuals

7. Audit Response Documentation

8. Collaborate with QA, Regulatory, IT, and Project teams to gather inputs and ensure document accuracy and clarity.

9. Translate complex technical and regulatory content into structured, user-friendly documentation.

FDA

11. Assist in preparing documentation for client audits, internal assessments, and regulatory inspections.

SharePoint

Role & responsibilities

Technology Hands on Exp : AWS, Azure, GCP, SAS, BI, Databricks, sFTP, SaaS, PaaS, IaaS

Domain: GDP, GxP, GAMP, CRO, 21 CFR Part 11, FDA, NDA, ALCOA+, QMS, SOP

Preferred candidate profile

We are striclty looking for System Validation side not For Medical Devices, Equipments or Instruments validation side

Relevant Work Experience/Job Requirements:

Computer System Validation (CSV)

GxP, 21 CFR Part 11, EU Annex 11, and GAMP 5

quality and compliance documentation

EDMS/QMS systems, LIMS, MES, and electronic signature platforms

collaborate with QA, IT, Manufacturing, and Regulatory teams

Must have Skill sets required:

1. Computer System Validation (CSV) Expertise Hands-on in preparing and executing VMP, URS, FS, RTM, IQ/OQ/PQ, and validation reports.

2. Regulatory & Compliance Knowledge Strong understanding of GxP, 21 CFR Part 11, EU Annex 11, GAMP 5, and data integrity principles.

3. Quality Documentation & Audit Readiness Skilled in SOPs, change control, CAPA, deviations, and maintaining audit-ready records.

4. Technical & System Knowledge Familiar with EDMS, QMS, LIMS, MES, and electronic signature platforms in regulated environments.

5. Cross-functional Collaboration & Communication Ability to work closely with QA, IT, Manufacturing, and Regulatory Affairs teams.

Technology Hands on Exp : AWS, Azure, GCP, SAS, BI, Databricks, sFTP, SaaS, PaaS, IaaS

Domain: GDP, GxP, GAMP, CRO, 21 CFR Part 11, FDA, NDA, ALCOA+, QMS, SOP

Other Skills:

Risk Assessment & Impact Analysis

Data Integrity & Audit Trail Review