Tailored Management · 1 day ago
Validation Engineer II - CSV and Compliance Support
Hillsboro, OR
Full-time
Onsite
Senior Level
$55.94/hr - $80.42/hr
5+ years expTailored Management is seeking a Validation Engineer II to provide Computer System Validation (CSV) and compliance support for IT/OT systems. This role involves maintaining validated system states, ensuring GMP compliance, and supporting documentation, testing, and quality processes.
ConsultingHuman ResourcesInformation Technology
Responsibilities
Support IT/OT system owners with lifecycle activities including maintenance, validation, testing, and documentation
Create and update CSV and lifecycle documentation for IT/OT systems such as DeltaV, PI, MES, SCADA, LyoPlus, FIT, BAS, and WAGIT
Execute and support annual system maintenance (MILE) activities, including development, review, and execution of installation and test protocols
Own and manage Quality Management System records including CAPAs, deviations, and planned events through closure
Conduct periodic system reviews by analyzing three years of deviation and event data, assessing validation impact, and preparing summary reports
Assist with procurement, development, integration, modification, operation, maintenance, and retirement of IT/OT systems
Support validation protocol generation, review, approval, and execution
Perform system maintenance tasks such as audit trail reviews and user account audits
Generate system reports and compliance metrics as requested
Partner with system and business process owners on system upgrades, patches, and changes to maintain GMP compliance
Support document management platforms such as Veeva, Condor, and eVal
Assist with administrative documentation tasks including formatting and routing
Collaborate with local and global stakeholders to complete validation and compliance initiatives
Participate in Quality Huddle meetings and provide quality metrics reporting
Ensure alignment with global validation standards, protocols, and policies
Qualification
Required
Bachelor's degree in Computer Science, Engineering, Life Sciences, or a related field (or equivalent experience)
Minimum 5 years of experience with Computer System Validation frameworks (CSV/CSA, GAMP), preferably within the pharmaceutical industry
Strong knowledge of GMP and regulatory requirements including 21 CFR Part 11, Annex 11, EU GMP Annex 1, GxP, and Data Integrity principles
Solid understanding of ISA-95 architecture, with hands-on experience supporting Level 2 and Level 3 systems (Level 1 experience is a plus)
Experience with system and data integrity risk assessments
Preferred
SCADA systems
OSI PI
Siemens Desigo
Rockwell FactoryTalk PharmaSuite
DeltaV
MES platforms and EBR recipe authoring
Systems administration and software development environments
Benefits
Weekly pay
Medical
Dental
Vision
Company
Tailored Management
Tailored Management is a staffing and recruiting company that offers information technology staffing and recruitment services.
501-1000 employees
H1B Sponsorship
Tailored Management 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
2024 (1)
2020 (2)
Funding
Current Stage
Late StageLeadership Team
Jeff Anderson
Managing Partner & Client Relations Executive
Savannah Deskins
Manager, Administration & Office of the CEO
Company data provided by crunchbase