Sharp DecisionsOne of the clients of Sharp Decisions is looking for a CSV Validation Engineer in Hillsboro, OR. This is an 100% onsite role and a 12-month contract with possible extension.
Work to support the ITOT System owners in tasks associated with the lifecycle of the computer system, ie, maintenance, validation, documentation, and testing.
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 years worth of planned and unplanned events, review impact on the systems validated state and drafting 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 demandWork 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, DeltaV, Manufacturing Execution Systems (MES) Systems administration and EBR 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.
Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing
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