Katalyst CRO · 8 hours ago
Validation Engineer II – CSV & Compliance
Hillsboro, OR
Full-time
Onsite
Senior Level
5+ years expKatalyst CRO is a company focused on supporting IT/OT system owners with computer system validation and compliance reporting. The role involves managing validation activities, ensuring compliance, and collaborating with stakeholders in GMP-regulated environments.
AnalyticsBiopharmaData ManagementHuman ResourcesQuality Assurance
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
Katalyst CRO
Katalyst CRO | Advancing Healthcare & Life Sciences with Expert Research & Regulatory Solutions Katalyst Healthcare & Life Sciences (Katalyst CRO) is a Global Contract Research and Knowledge Process Outsourcing Organization (CRO) dedicated to driving innovation in research, regulatory compliance, and quality excellence for pharmaceutical, biotechnology, and medical device companies worldwide.
51-200 employees
H1B Sponsorship
Katalyst CRO has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (37)
2024 (14)
2023 (24)
2022 (52)
2021 (54)
2020 (39)
Funding
Current Stage
Growth StageLeadership Team
John Patil
Recruiter, Pharma/CRO Staffing Division
Recent News
2024-04-07
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