Validation Engineer II - CSV and Compliance Support
Company: Tailored Management
Location: Hillsboro
Posted on: March 7, 2026
|
|
|
Job Description:
Role: Validation Engineer II - CSV and Compliance Support
Location: Hillsboro, OR -97124 Contract: 12 Months - possibility
for extension or FTE conversion Payrate: $62.66 - $94.96/hr (W2)
Benefits Responsibilities: Work to support the ITOT System owners
in tasks associated with the lifecycle of computer system, ie.
maintenance, validation, documentation, testing. Create/update
Computer System validation and lifecycle support documentation, as
the need arises, for ITOT computer systems (DeltaV, PI, MES, SCADA,
LyoPLus, FIT, Client, 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 systems 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.
Attend Quality Huddle Meetings Provide Quality Metrics Align with
global Validation protocols and policies Minimum Requirements:
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. TMN
Keywords: Tailored Management, Gresham , Validation Engineer II - CSV and Compliance Support, IT / Software / Systems , Hillsboro, Oregon
