Validation Engineer - CSV and Compliance Support

Avispa Technology•Hillsboro, OR

5d•$60 - $70•Onsite

About The Position

A leading biotechnology company is seeking a Validation Engineer - CSV and Compliance Support . T he successful candidate will support the ITOT System owners in tasks associated with the lifecycle of computer system, ie. maintenance, validation, documentation, and testing.

Requirements

5 years of experience in Computer systems Validation frameworks (CSV/CSA, GAMP), preferably in the Pharma industry.
Bachelor of Science or equivalent in computer science, engineering, life sciences, or related field.
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.

Nice To Haves

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.
Experience working with Level 1 systems is a plus.

Responsibilities

Create/update Computer System validation and lifecycle support documentation, as the need arises, for ITOT computer systems (DeltaV, PI, MES, SCADA, BAS). Systems will fall between Level 2 and 3 of the ISA-95 model
Help perform (annual system maintenance) activities for ITOT Systems.
Own Quality Management System records (CAPA, Planned Events, Deviations) and orchestrate completion of activities needed.
Perform system periodic review.
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 protocol.
Collaborate with local and global stakeholders in defining and completing validation and compliance activities.