CSV Consultant - Manufacturing Validation

Experience: 6-10 Years

Role Summary

We are looking for a hands-on Computer System Validation (CSV) Consultant with strong experience in pharma / biotech / medical device manufacturing environments . This role requires a candidate with end-to-end CSV project execution experience , especially in manufacturing validation and QMS-regulated systems .

The ideal candidate should have proven experience validating systems such as MES, SAP, TrackWise, ServiceNow, or Veeva Vault , along with exposure to bio-clinical systems like CTMS, EDC, or Lab systems .

Core Requirement The candidate must have:

- Strong end-to-end CSV project experience
- Proven experience in manufacturing validation environments
- Hands-on validation exposure on systems such as:
- MES
- SAP
- TrackWise
- ServiceNow
- Veeva Vault
- Exposure to bio-clinical systems such as:
- CTMS
- EDC
- Lab systems
- Good understanding and practical experience in QMS processes
- Reliable career progression within CSV / validation / compliance roles

Key Responsibilities

Computer System Validation

- Execute end-to-end CSV lifecycle activities across regulated systems
- Lead/support IQ, OQ, PQ activities
- Prepare, review, and execute validation deliverables such as:
- Validation Plan
- URS
- FRS
- Risk Assessments
- RTM
- Validation Summary Report
- Ensure validation activities are aligned with regulatory and internal quality expectations

Compliance and Regulatory
- Work within GxP-regulated environments
- Ensure compliance with:
- 21 CFR Part 11
- GAMP 5
- ICH Q9
- Support GxP assessments , functional risk assessments, and audit readiness




- Participate in regulatory, internal, and client audit support activities

Manufacturing / QMS / System Validation
- Perform validation in pharma manufacturing / medical device validation environments
- Support validation of systems linked to manufacturing, quality, and clinical processes
- Work on QMS-related workflows , deviations, CAPA, change control, and discrepancy handling
- Maintain end-to-end traceability and audit-ready documentation

Cloud / Vendor / Hosted Systems
- Support validation of cloud-based / hosted systems where applicable
- Participate in vendor qualification and assessment activities
- Review vendor compliance documentation including SOC 1 / SOC 2 where required

Required Experience

- 6-10 years of relevant experience in Computer System Validation
- Strong experience in pharmaceutical, biotechnology, or medical device industries
- Proven hands-on experience in manufacturing validation
- Strong exposure to regulated systems validation , not just QA/QC or document coordination
- Good experience in QMS processes and compliance-driven validation activities

Must-Have Skills

- End-to-end CSV execution
- IQ / OQ / PQ
- 21 CFR Part 11
- GAMP 5
- ICH Q9
- GxP environment
- Validation document authoring/review
- Manufacturing validation
- QMS exposure
- System exposure to MES / SAP / TrackWise / ServiceNow / Veeva Vault

Good to Have

- Exposure to CTMS / EDC / Lab systems
- Cloud validation experience
- Vendor qualification / supplier assessment
- Support for global regulatory audits
- Experience in consulting or client-facing environments

📌 CSV Consultant - Manufacturing Validation (India)
🏢 TRUGlobal
📍 India