DeltaV CSV Lead Engineer – Life Sciences Validation

Valspec

Redmond (WA)

On-site

USD 120,000 - 180,000

Full time

14 days+

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Job summary

Valspec is seeking a Lead Validation Engineer (CSV/DeltaV) to support a major biologics manufacturing operation in the Seattle area. This senior role requires strong DeltaV expertise and a proven track record leading validation activities within GMP environments.

The successful candidate will provide technical leadership for computerized system validation, develop and execute plans, and collaborate with cross-functional teams to ensure compliant system implementation and operation.

Qualifications

8+ years of Computer System Validation experience in GMP-regulated pharma/biotech.
Hands-on DeltaV validation experience is required.
Experience leading validation projects and coordinating cross-functional teams.
Strong knowledge of GAMP 5, CSA/CSV methodologies, and data integrity principles.
Excellent technical writing and client-facing skills.

Responsibilities

Lead CSV activities for DeltaV-based manufacturing systems.
Develop and execute validation deliverables ( plans, RTMs, IQ/OQ/IOQ, reports).
Support DeltaV system implementations, upgrades, and modifications.
Coordinate validation across Automation, Engineering, Manufacturing, IT and Quality.
Mentor junior validation engineers and drive risk-based validation practices.