BEPC Inc. - Business Excellence Professional Consulting · 1 day ago
Validation Engineer II - CSV and Compliance Support - 29200_SE
Hillsboro, OR
Full-time
Onsite
Senior Level
$79/hr - $84/hr
5+ years expBEPC Inc. is a 100% employee-owned company providing consulting and staffing solutions across various industries. They are seeking an experienced Validation Engineer II to support IT/OT system owners in a regulated GMP environment, focusing on validation, compliance, and lifecycle management of manufacturing and automation systems.
BiotechnologyConsulting
Responsibilities
Support IT/OT system owners across the full system lifecycle, including maintenance, validation, testing, documentation, upgrades, and retirement
Create, update, and maintain validation and lifecycle documentation in alignment with global validation policies and procedures
Perform annual maintenance and lifecycle (MILE) activities, including audit trail reviews and user/account audits
Own and manage Quality Management System (QMS) records such as CAPAs, Planned Events, and Deviations
Conduct system periodic reviews, including data collection and reporting on system events from the past three years
Support procurement, development, integration, operation, and decommissioning of IT/OT systems
Generate, execute, and approve validation protocols (IQ/OQ/PQ or CSA-based approaches)
Create and maintain system reports, quality metrics, and support Quality Huddles
Support system upgrades, patching, and configuration changes to ensure ongoing GMP compliance
Support document management systems such as Veeva, Condor, and eVal
Perform administrative documentation tasks including formatting, routing, and controlled document updates
Collaborate with local and global stakeholders to ensure consistent validation and compliance practices
Qualification
Required
Bachelor's degree (or equivalent) in Computer Science, Engineering, Life Sciences, or a related field
Minimum 5 years of experience with Computer Systems Validation frameworks (CSV/CSA, GAMP), preferably in a pharmaceutical or regulated manufacturing environment
Strong understanding of ISA-95 architecture with experience supporting Level 2 and Level 3 systems
Working knowledge of FDA and EU GMP regulations, including 21 CFR Part 11, Annex 11, and Annex 1
Solid understanding of GxP principles, data integrity requirements, and system/data integrity risk assessment concepts
Preferred
Experience with automation and manufacturing systems such as DeltaV, OSI-PI, MES, SCADA, LyoPLus, FIT, BAS, and WAGIT
Familiarity with Siemens Desigo and Rockwell FactoryTalk PharmaSuite
Experience with systems administration, EBR recipe authoring, or regulated system support
Prior experience supporting validation activities in a global or multi-site environment
Benefits
Medical
Dental
Vision
Life Insurance
Company
BEPC Inc. - Business Excellence Professional Consulting
BEPC Incorporated provides Technical Engineering and Information Technology Project Management services to Fortune 500 companies in the industries: Life Science, Engineering, Manufacturing, Information Technologies, Advanced Technologies, Automotive, and Construction.
201-500 employees
H1B Sponsorship
BEPC Inc. - Business Excellence Professional Consulting 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 (1)
2023 (3)
2020 (3)
Funding
Current Stage
Growth StageLeadership Team
Oscar Casillas
President and CEO
Andrew Casillas
Human Resources Partner
Company data provided by crunchbase