Ecocareers · 18 hours ago
Validation Engineer II – CSV & Compliance
Hillsboro, OR
Full-time
Onsite
Senior Level
5+ years expConfidential company is seeking a Validation Engineer II to support IT/OT system owners with computer system validation and compliance for GMP-regulated manufacturing systems. The role involves performing lifecycle activities, managing documentation, and ensuring compliance during system upgrades and changes.
Staffing & Recruiting
Responsibilities
Perform CSV/CSA lifecycle activities: validation, testing, documentation, and periodic reviews
Create/update and execute validation protocols (IQ/OQ/PQ, test scripts, reports)
Support annual system maintenance (MILE) and system audits
Manage QMS records (CAPA, Deviations, Planned Events)
Ensure GMP & data integrity compliance during system upgrades/changes
Collaborate with system owners and global stakeholders
Support document management systems and compliance reporting
Qualification
Required
Bachelor's degree in engineering, Computer Science, Life Sciences, or related field
5+ years of CSV experience (GAMP / CSA) in Pharma or regulated industry
Strong experience with ISA-95 Level 2 & Level 3 systems
Hands-on knowledge of FDA 21 CFR Part 11, EU GMP, Annex 11, GxP & Data Integrity
Experience supporting IT/OT manufacturing systems validation and compliance
Preferred
Experience with DeltaV, MES, SCADA, OSI-PI, Siemens Desigo, Rockwell FactoryTalk, Client
Experience with Veeva, Condor, eVal Roche or similar DMS tools
MES administration, EBR recipe authoring
Exposure to Level 1 systems
Strong compliance reporting and metrics experience
Company
Ecocareers
Ecocareers provides a specialized job search for careers that make a difference.
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase