Validation Engineer (CSV)

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. Lead Validation Engineer (CSV / DeltaV) Valspec | Seattle, WAFull-Time | Hybrid Client Site Support About Valspec Valspec, part of the Proconex family of companies, is a leading provider of Computer System Validation (CSV), Computer Software Assurance (CSA), Commissioning & Qualification (CQV), and manufacturing systems consulting services for the life sciences industry. Valspec partners with pharmaceutical and biotechnology manufacturers to deliver compliant, reliable, and efficient systems throughout the project lifecycle. Position Summary Valspec is seeking a Lead Validation Engineer (CSV/DeltaV) to support a major biologics manufacturing operation in the Seattle area. This role is ideal for a senior validation professional with extensive DeltaV experience and a proven track record leading validation activities within GMP-regulated pharmaceutical and biotechnology facilities. The successful candidate will provide technical leadership for computerized system validation efforts, support project execution, and work closely with Automation, Engineering, Manufacturing, Quality, and IT teams to ensure compliant system implementation and operation. The role includes both strategic validation planning and hands-on protocol development and execution.  Key Responsibilities Lead Computer System Validation (CSV) activities for DeltaV-based manufacturing systems. Develop and execute validation deliverables including: Validation Plans Risk Assessments Requirements Traceability Matrices (RTMs) Installation & Operational Qualification Protocols (IQ/OQ/IOQ) Validation Summary Reports Support DeltaV system implementations, upgrades, expansions, and modifications. Review and approve engineering documentation, functional specifications, design specifications, and configuration documentation. Coordinate validation activities across Automation, Engineering, Manufacturing, IT, and Quality organizations. Lead protocol execution, deviation investigations, issue resolution, and documentation closeout. Support change control activities and validation impact assessments. Provide technical guidance and mentorship to junior validation engineers. Drive risk-based validation and software assurance practices aligned with current industry expectations. Support startup, commissioning, qualification, and operational readiness activities...