BEPC Inc. - Business Excellence Professional Consulting · 5 hours ago
Validation Engineer II - CSV and Compliance Support - 29200_AV
Hillsboro, OR
Contract
Onsite
Senior Level
$81/hr - $84/hr
5+ years expBEPC Inc. is actively looking for a Validation Engineer II to support ITOT System Owners in the Hillsboro, OR area. This role involves ensuring the lifecycle maintenance, validation, documentation, and testing of computer systems to maintain GMP compliance.
BiotechnologyConsulting
Responsibilities
Support ITOT System Owners in lifecycle activities such as maintenance, validation, documentation, and testing
Create and update computer system validation and lifecycle documentation for ITOT computer systems
Perform annual system maintenance (MILE) activities, including creating, updating, executing, or reviewing installation and test protocols
Own Quality Management System records (CAPA, Planned Events, Deviations) and coordinate completion of required activities
Perform system periodic reviews, including:
Data collection from the deviations database for the past 3 years of planned and unplanned events
Review of impact on the system’s validated state
Drafting periodic review reports
Support System Owner squads in procurement, development, integration, modification, operation, maintenance, and retirement of ITOT systems
Support validation activities, including generation, approval, and execution of validation protocols
Assist System Owners with system maintenance activities such as periodic audit trail reviews and account audits
Create reports for various systems on demand
Work with System Owners and Business Process Owners on upgrades, patching, and system changes to ensure GMP compliance
Support document management systems (Veeva, Condor, eVal)
Support administrative tasks including document formatting and routing
Collaborate with local and global stakeholders to define and complete validation and compliance activities
Attend Quality Huddle Meetings
Provide Quality Metrics
Align with global validation protocols and policies
Qualification
Required
Bachelor of Science or equivalent in computer science, engineering, life sciences, or a related field
Minimum 5 years of experience in Computer Systems Validation frameworks (CSV/CSA, GAMP), preferably in the pharmaceutical industry
Good understanding of the ISA-95 model
Required experience working with Level 2 and Level 3 systems
Knowledge of FDA regulations and guidance, including: CFR 21 FDA Part 11, Annex 11, EU GMP Annex 1, GxP practices
Knowledge of Data Integrity principles
Good understanding of system and data integrity risk assessment concepts
Preferred
Knowledge of or experience with: SCADA, OSI-PI, Siemens Desigo, Rockwell FactoryTalk Pharmasuite, DeltaV, Manufacturing Execution Systems (MES), Systems administration, EBR recipe authoring, Software development
Experience working with Level 1 systems
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