ITOT Computer System Validation Contractor

A client of Sharp Decisions Inc. is looking for System Validation to be based in Hillsboro OR 97124.

Location : Hillsboro OR 97124

Pay : : 87 / hr on W2

Role Minimum Requirements

Bachelor of Science or equivalent in computer science, engineering, life sciences, or related

field.

Minimum 6+ years’ experience in IT, OT or Software Technical Writing, Quality Systems, and

Validation (CSV / CSA, GAMP), preferably in a regulated 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.

Good 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 risk assessment concepts.

Technical skills

Knowledge of or experience with the following technical areas is a plus : System

administration, software development, networking, server administration, MES Systems administration and recipe authoring, Industrial Data and manufacturing controls systems.

Familiarity with IT Service Management, Quality and Document Management systems such as Veeva, HP ALM, Valgenesis, and ServiceNow, is a plus