Lead Validation Engineer

Non Headquarterslead

QA & TestingValidation Engineer

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Quick Summary

Overview

Technical Tools

QA & TestingValidation Engineer

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.

Valspec is seeking an experienced Lead Validation Engineer to support a major SCADA and Environmental Monitoring System modernization project at a regulated manufacturing facility in Southern California.

This role will lead Computer System Validation (CSV), commissioning, qualification, and release activities for SCADA, PLC, environmental monitoring, virtual infrastructure, databases, historian interfaces, and manufacturing system integrations. The project will follow a Waterfall SDLC and risk-based validation approach within a GxP environment.

Responsibilities

~1 min read

→Lead validation activities for SCADA, PLC, and Environmental Monitoring System upgrades.
→Develop and execute validation documentation, including Validation Plans, URS, risk assessments, IQ/OQ/PQ protocols, Traceability Matrices, and Validation Summary Reports.
→Lead qualification of control systems, virtual infrastructure, servers, SQL databases, historian interfaces, and operator workstations.
→Develop and execute risk-based testing for alarms, audit trails, user access, data integrity, backup/recovery, and system interfaces.
→Support data migration, UAT, PQ, discrepancy resolution, and system release.
→Coordinate validation activities across Quality, Automation, Engineering, IT, Operations, and external vendors.
→Maintain project schedules and communicate validation status, risks, and issues to project leadership.

Requirements

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Bachelor’s degree in Engineering, Life Sciences, Computer Science, or related technical field.
Strong validation experience within pharmaceutical, biotechnology, or other GxP-regulated manufacturing environments.
Experience leading Computer System Validation or automation validation projects.
Hands-on experience with IQ/OQ/PQ, risk assessments, requirements, traceability, deviations, and validation reporting.
Experience validating SCADA, PLC, Environmental Monitoring, historian, database, or manufacturing control systems.
Strong understanding of GxP, data integrity, audit trails, electronic records, and risk-based validation.
Ability to work on-site in Southern California.Preferred Experience.

Nice to Have

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GE Digital iFIX or similar SCADA platforms.
Rockwell PLCs and industrial control systems.
VMware, Windows Server, and SQL Server.
Process historians and data migration.
Kneat or similar electronic validation systems.
Previous experience leading complex automation or computerized system validation projects.

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.