C4 Technical Services · 20 hours ago
Validation Engineer II - CSV and Compliance Support - Hillsboro, OR
Hillsboro, OR
Contract
Onsite
Senior Level
5+ years expC4 Technical Services is seeking a Validation Engineer II to support the ITOT System owners in managing the lifecycle of computer systems. The role involves creating and updating validation documentation, performing system maintenance activities, and ensuring compliance with quality management systems.
Information TechnologyTelecommunications
Responsibilities
Create/update Computer System validation and lifecycle support documentation, as the need arises, for ITOT computer systems (DeltaV, PI, MES, SCADA, LyoPLus, FIT, BAS, WAGIT). Systems will fall between Level 2 and 3 of the ISA-95 model
Help perform MILE (annual system maintenance) activities for ITOT Systems. For example, create, update, execute, or review installation protocols, test protocols, etc
Own Quality Management System records (CAPA, Planned Events, Deviations) and orchestrate completion of activities needed
Perform system periodic reviews- This entails performing data collection from the deviations database on the past 3 year’s worth of planned and unplanned events, review impact on system’s validated state and draft reports
Support System Owner squad in the overall procurement, development, integration, modification, operation, maintenance, and retirement of ITOT systems
Support validation activities, generation, approval and execution of validation protocols
Assist System Owners in system maintenance activities such as Periodic System Audit Trail Review, account audits, etc
Creating reports for various systems on demand
Work with the System Owners and Business Process Owners for the upgrade/patching and changes to the system to ensure GMP compliance
Support on documents management systems (Veeva, Condor, eVal Roche)
Support the team with administrative tasks, such as document formatting, document routing
Collaborate with local and global stakeholders in defining and completing 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 related field
Minimum 5 years experience in Computer systems Validation frameworks (CSV/CSA, GAMP), preferably in the Pharma industry
Good understanding of the ISA-95 model. Experience working with Level 2 and Level 3 systems is required. Experience working with Level 1 systems is a plus
Knowledge of Food and Drug Administration regulations/guidance (i.e. CFR 21 FDA Part 11, Annex 11, EU GMP Annex 1, GxP practices) and Data Integrity principles
Good understanding of system and data integrity risk assessment concepts
Preferred
Knowledge of or experience with the following technical areas is preferred: SCADA, OSI-PI, Siemens Desigo, Rockwell Factory Talk Pharmasuite, DeltaV, Manufacturing Execution Systems (MES) Systems administration and EBR recipe authoring, software development
Company
C4 Technical Services
C4 Technical Services is an information technology company offering IT and telecommunication services
501-1000 employees
Funding
Current Stage
Late StageLeadership Team
Mary Gaida
CFO
Anderson Cooper
C/O installer( power tech)/wireless tech
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