Lead CSV Engineer - Pharma - Houston

Our pharma client is looking to hire a Lead CSV Engineer. This is a remote with up to 35% travel role in Houston, TX. We gladly consider qualified candidates who are ready to relocate to Houston area and be able to work on-site 1-2 days/week.

*This role is a 3-year contract opportunity. We can do W2 (with health and 401k benefits) or C2C*

We are seeking experienced Lead CSV Engineer to support a large-scale greenfield pharmaceutical manufacturing project. These consultant will lead Computer System Validation (CSV) activities for one of the areas across manufacturing, laboratories, warehouses, utilities, and supporting infrastructure.

Key Requirements:

• 10+ years of Computer System Validation (CSV) experience in pharmaceutical or biotechnology environments
• Strong leadership experience supporting large-scale GMP automation projects
• Expertise with Emerson DeltaV, Rockwell PLCs, vendor-packaged equipment, and manufacturing automation systems
• Hands-on experience with CSV strategies, Validation Plans, Test Plans, risk assessments, traceability matrices, and qualification protocols
• Deep knowledge of GMP, GAMP 5, 21 CFR Part 11, EU Annex 11, CSA, and risk-based validation methodologies
• Experience with Kneat electronic validation software (preferred)
• Familiarity with AVEVA PI Historian, FactoryTalk AssetCentre, LogMate, WIN-911, MES integrations, ISA-88, ISA-95, and batch control systems
• Experience supporting commissioning, qualification, data integrity, change control, deviations, and regulatory inspection readiness

Preferred:

• Experience supporting greenfield pharmaceutical facilities
• Small molecule and/or oligonucleotide manufacturing experience
• Familiarity with Veeva Vault and OT infrastructure validation

If you're an experienced CSV professional with a strong automation validation background and are interested in a high-impact pharmaceutical manufacturing project in Houston, we'd love to connect.

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