Validation Engineer

Position Title:

Validation Engineer II - CSV and Compliance Support

Work Location:

Hillsboro, OR (Onsite) Assignment Duration: 12 months (possibility of extension)

Position Summary:

Work to support the ITOT System owners in tasks associated with the lifecycle of computer system, i.e. maintenance, validation, documentation, testing. Create/update Computer System validation and lifecycle support documentation, as the need arises, for ITOT computer systems (Delta

V, 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.
• Align with global Validation protocols and policies.

• 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.
• Knowledge of or experience with the following technical areas is preferred: SCADA, OSI-PI, Siemens Desigo, Rockwell Factory Talk Pharmasuite, Delta
  
  V, Manufacturing Execution Systems (MES) Systems administration and E  recipe authoring, software development.
• 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.