Validation Engineer II - CSV & Compliance

Hillsboro, OR, US • Posted 2 hours ago • Updated 2 hours ago

Full Time

On-site

Fitment

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Job Details

Skills

Testing
Documentation
IQ
OQ
PQ
Test Scripts
Auditing
Management
QMS
Corrective And Preventive Action
Collaboration
Document Management
Computer Science
Life Sciences
Computerized System Validation
GAMP
Pharmaceutics
GMP
GxP
Data Integrity
Manufacturing
SCADA
OSI
Siemens
Veeva
DMS
MES
Regulatory Compliance
Reporting

Summary

Job Description:
Support IT/OT system owners with computer system validation (CSV), lifecycle documentation, compliance reporting, and ongoing system maintenance for GMP-regulated manufacturing systems (ISA-95 Level 2 & 3).
Responsibilities:

Perform CSV/CSA lifecycle activities: validation, testing, documentation, and periodic reviews.
Create/update and execute validation protocols (IQ/OQ/PQ, test scripts, reports).
Support annual system maintenance (MILE) and system audits.
Manage QMS records (CAPA, Deviations, Planned Events).
Ensure GMP & data integrity compliance during system upgrades/changes.
Collaborate with system owners and global stakeholders.
Support document management systems and compliance reporting.

Mandatory Skills / Requirements:

Bachelor's degree in engineering, Computer Science, Life Sciences, or related field.
5+ years of CSV experience (GAMP / CSA) in Pharma or regulated industry.
Strong experience with ISA-95 Level 2 & Level 3 systems.
Hands-on knowledge of FDA 21 CFR Part 11, EU GMP, Annex 11, GxP & Data Integrity.
Experience supporting IT/OT manufacturing systems validation and compliance

Preferred Skills:

Experience with DeltaV, MES, SCADA, OSI-PI, Siemens Desigo, Rockwell FactoryTalk, Client.
Experience with Veeva, Condor, eVal Roche or similar DMS tools.
MES administration, EBR recipe authoring.
Exposure to Level 1 systems.
Strong compliance reporting and metrics experience.

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.

Dice Id: 91116760
Position Id: 545b3740b0c6accc397cb13a16954472
Posted 2 hours ago

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Validation Engineer II - CSV & Compliance

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Job Details

Skills

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