Senior Validation Engineer - DeltaV CSV Lead (GMP)
Valspec
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Benefits offered by this job
Job summary
Valspec, a global provider of CSV, CSA, CQV and manufacturing systems consulting for life sciences, seeks a Lead Validation Engineer (CSV/DeltaV) to support a major biologics operation in Seattle. The role requires 8+ years of experience in GMP environments, hands-on DeltaV validation, and proven ability to lead cross-functional teams across Automation, Engineering, Manufacturing, Quality and IT.
You will develop validation deliverables, mentor others, and drive risk-based validation to ensure
Qualifications
- Bachelor's degree in engineering or life sciences.
- 8+ years of CSV experience in GMP pharmaceutical/biotech.
- Hands-on DeltaV validation experience required.
Responsibilities
- Lead CSV activities for DeltaV-based manufacturing systems.
- Develop IQ/OQ/IOQ, validation plans, and RTMs.
- Coordinate validation with Automation, Engineering, Manufacturing, IT, and Quality.
- Mentor junior validation engineers and drive risk-based validation.
- Support startup, commissioning, qualification, and readiness activities.
Skills
Education
Tools
Job description
Valspec, a global provider of CSV, CSA, CQV and manufacturing systems consulting for life sciences, seeks a Lead Validation Engineer (CSV/DeltaV) to support a major biologics operation in Seattle. The role requires 8+ years of experience in GMP environments, hands-on DeltaV validation, and proven ability to lead cross-functional teams across Automation, Engineering, Manufacturing, Quality and IT.
You will develop validation deliverables, mentor others, and drive risk-based validation to ensure
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