CSV Consultant - Manufacturing Validation

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
• Stable 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