Urgent Need ! Direct Client Requirement. Job Title: Computer Systems Validation (CSV) Consultant – GMP Manufacturing. Engagement: Contract. Work Mode: Remote Role Overview
We are looking for an experienced Computer Systems Validation (CSV) Consultant to support GMP-regulated manufacturing environments. The ideal candidate will ensure that regulated systems meet compliance, quality, and validation standards throughout the system lifecycle. Experience with IBM Maximo or similar EAM platforms is highly preferred. Key Responsibilities
Lead and execute CSV activities in GMP-regulated manufacturing environments
Author and review validation documentation (VMP, URS, FRS, IQ/OQ/PQ, Traceability Matrix)
Ensure compliance with FDA, GxP, 21 CFR Part 11, and other applicable regulations
Support validation of manufacturing, quality, and enterprise asset management systems
Partner with QA, IT, and business teams during system implementations, upgrades, and enhancements
Provide audit support and ensure inspection readiness Required Qualifications
Proven experience in Computer Systems Validation (CSV) within GMP manufacturing environments
Strong working knowledge of GxP regulations and validation lifecycle methodologies
Experience validating enterprise systems (MES, QMS, EAM, ERP, etc.)
Excellent documentation, analytical, and stakeholder communication skills Preferred Qualifications
Experience with IBM Maximo or similar EAM platforms
Background in pharmaceutical, biotech, or other regulated manufacturing industries If you are a CSV professional with strong GMP experience and looking for a remote contract opportunity, we’d love to connect.
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