Validation Engineer II - CSV & Compliance

Hillsboro, OR, US • Posted 23 days ago • Updated 26 minutes 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 23 days ago
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