Job Title: Computer Systems Validation (CSV) Consultant GMP Manufacturing
Engagement: Contract
Work Mode: Hybrid / Remote (based on client needs)
Role Overview:
We are seeking an experienced Computer Systems Validation (CSV) Consultant to support GMP-compliant manufacturing environments. The consultant will ensure regulated systems meet compliance, quality, and validation standards across their lifecycle. Experience with IBM Maximo or similar EAM systems is highly preferred.
Key Responsibilities:
Lead and execute CSV activities in GMP-regulated manufacturing environments
Develop and review validation deliverables (VMP, URS, FRS, IQ/OQ/PQ, Traceability Matrix)
Ensure compliance with FDA, GxP, 21 CFR Part 11, and relevant industry regulations
Support validation of manufacturing, quality, and asset management systems
Collaborate with QA, IT, and business stakeholders during system implementation and upgrades
Provide audit support and ensure inspection readiness
Required Qualifications:
Strong experience in Computer Systems Validation (CSV) within GMP manufacturing
Hands-on knowledge of GxP regulations and validation methodologies
Experience validating enterprise systems (MES, QMS, EAM, ERP, etc.)
Excellent documentation and stakeholder communication skills
Preferred Qualifications:
Experience with IBM Maximo or similar asset management systems
Pharmaceutical, biotech, or regulated manufacturing industry background
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