IT Validation Lead (GxP / CSV)

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Overview

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Valspec—a global provider of system validation and lifecycle services—provides commissioning and qualification of computerized systems for clients in the Life Sciences industry. Established in 1999, Valspec’s mission is to provide a wide spectrum of services that help its clients meet their capital project and lifecycle maintenance goals.

Valspec’s projects are critical to the industry, and to the people who rely on its products. Many projects ensure that life-changing drugs are available to those who need them; others streamline production to meet demand at a lower cost, allowing for the discovery of new and innovative therapies.

A leading biopharmaceutical manufacturer in the San Diego area is seeking a Senior CSV Quality Engineer to join their Quality organization for a long-term, onsite contract engagement. This is an opportunity to own compliance oversight for computerized systems across lab, manufacturing, and quality functions — safeguarding the integrity of systems that support life-changing therapies.

About the Role

~1 min read

You'll join the Quality organization as the go-to compliance expert for computerized systems, partnering closely with senior Quality leadership to ensure IT and automated systems across the site meet global regulatory expectations. This role blends hands-on validation execution with quality oversight — you'll be the person Quality and IT turn to when a system needs to be audit-ready, not just functional. It's a chance to work across the full breadth of a biopharma site's digital footprint, from lab instrumentation to manufacturing and enterprise systems.

Responsibilities

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→Provide Quality Assurance oversight and technical validation expertise for computerized systems across laboratory, manufacturing, and quality support functions
→Ensure systems are implemented, validated, and maintained in compliance with FDA 21 CFR Part 11, EU Annex 11, and GAMP 5
→Review and approve validation lifecycle documentation, including URS, validation plans, protocols (IQ/OQ/PQ), and summary reports
→Assess computerized system changes for compliance impact and guide appropriate validation response
→Support data integrity initiatives, audit trail review, and electronic records/electronic signature compliance
→Partner with IT, Quality, and system owners to identify and remediate compliance gaps
→Support internal audits and regulatory inspections as the subject matter expert for computerized system compliance
→Contribute to change control, deviation, and CAPA processes involving computerized systems

Required:

5+ years of experience in Computer System Validation (CSV) or IT Quality within a GxP-regulated life sciences environment
Strong working knowledge of FDA 21 CFR Part 11, EU Annex 11, and GAMP 5
Direct experience authoring and/or reviewing validation lifecycle documentation (URS, protocols, reports)
Experience supporting data integrity and audit readiness for computerized systems
Bachelor's degree in a relevant scientific, engineering, or technical discipline, or equivalent experience
Strong written and verbal communication skills, with comfort working cross-functionally with Quality and IT teams

Preferred:

Experience validating laboratory, manufacturing, or enterprise/MES-type systems
Familiarity with risk-based validation approaches (e.g., Computer Software Assurance)
Prior experience supporting regulatory inspections or internal audits

Location: San Diego area (100% onsite)
Employment type: Contract, 12+ months
Pay rate: $65–$80/hour (W2)

What We Offer

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At Valspec, we offer more than just a job — we provide a career experience rooted in a standout culture, collaborative environment, and a strong sense of ownership. As an Employee Stock Ownership Plan (ESOP) company, every team member has a stake in our success, fostering a shared commitment to excellence and innovation. We also offer a highly competitive benefits package, including:

✓Premium medical coverage

✓401(k) with company match

✓Tuition reimbursement

✓Unique performance incentives

✓And more — all designed to support your growth, well-being, and future.