valspec
Validation Engineer (CSV)
At a Glance
- Location
- Non-Headquarters
- Experience
- 8+ years
- Posted
- 2026-07-28T15:38:32-04:00
Key Requirements
Required Skills
Certifications
- GMP
Domain Knowledge
- Automation
- Biotech
- Engineering
- Manufacturing
- Medical
- Pharmaceutical
Benefits & Perks
including: Premium medical coverage 401(k) with company match Tuition reimb
Requirements
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.
Responsibilities
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.
Lead Computer System Validation (CSV) activities for DeltaV-based manufacturing systems.
About the Company
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.