Overview
On Site
USD 87.00 per hour
Full Time
Skills
Science
Computer Science
Life Sciences
Technical Writing
Quality Management
Computerized System Validation
GAMP
GMP
GxP
Data Integrity
Risk Assessment
Software Development
Computer Networking
Server Administration
MES
System Administration
Manufacturing
IT Service Management
Document Management
Veeva
HP ALM
ServiceNow
Job Details
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
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
Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.