Lead Validation Engineer (CSV / DeltaV)

Location: Seattle, WA | Duration: Long Term

About the Role

We are seeking a Lead Validation Engineer (CSV / DeltaV) to support a major biologics manufacturing operation in the Seattle area. The ideal candidate will have extensive experience in Computer System Validation (CSV), hands-on expertise with DeltaV systems, and a proven track record leading validation activities in GMP-regulated pharmaceutical or biotechnology environments. This role involves technical leadership, validation planning, protocol development, execution, and collaboration with cross-functional teams to ensure compliant system implementation and operation.

Responsibilities

• Lead Computer System Validation (CSV) activities for DeltaV-based manufacturing systems.
• Develop and execute Validation Plans, Risk Assessments, Requirements Traceability Matrices (RTMs), IQ/OQ/IOQ Protocols, and Validation Summary Reports.
• Support DeltaV system implementations, upgrades, expansions, and modifications.
• Review and approve engineering documentation, functional specifications, design specifications, and configuration documents.
• Coordinate validation activities across Automation, Engineering, Manufacturing, IT, and Quality teams.
• 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 GAMP 5 and current industry standards.
• Support startup, commissioning, qualification, and operational readiness activities.
• Participate in project planning, scheduling, resource coordination, and stakeholder communications.

Requirements

• Bachelor's degree in Engineering, Computer Science, Life Sciences, or a related technical discipline.
• 8+ years of Computer System Validation (CSV) experience within GMP-regulated pharmaceutical or biotechnology environments.
• Hands-on validation experience with DeltaV systems is required.
• Experience leading validation projects and coordinating cross-functional teams.
• Strong experience developing and executing Validation Plans, Risk Assessments, RTMs, IQ/OQ Protocols, and Validation Summary Reports.
• Strong knowledge of GAMP 5, CSA/CSV methodologies, 21 CFR Part 11, Data Integrity principles, and GMP documentation practices.
• Experience supporting biologics or pharmaceutical manufacturing facilities.

Qualifications

• Experience with DeltaV Batch, MES platforms, manufacturing automation systems, infrastructure qualification, and Commissioning & Qualification (C&Q) activities is highly desirable.
• Previous experience serving as a Validation Lead or Project Lead or working in a consulting environment is a plus.
• Excellent technical writing, communication, leadership, and client-facing skills.