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Orion Innovation

Computer Systems Validation Engineer

  • Confirmed live in the last 24 hours
  • No salary listed
  • Mid level
  • Contract
  • On-site · Olympia, WA
  • 4+ yrs exp
  • Added 1 month ago

About this role

Orion Innovation seeks a Computer Systems Validation Engineer to lead validation activities for GxP electronic systems and Manufacturing Execution Systems (MES) in a regulated pharmaceutical/life sciences environment. The role involves authoring CSV documentation, managing test execution, and ensuring compliance with cGMP and regulatory requirements throughout the validation lifecycle.

What you'll do

  • Author, review, and approve computer systems validation documentation
  • Support test execution and document test failures while ensuring alignment with internal procedures
  • Partner with Business Owners and Technical Owners to develop requirements and specifications for GxP systems
  • Ensure validation tasks are documented in accordance with BMS procedures and regulations
  • Develop and maintain CSV deliverables including validation plans, test scripts, and summary reports
  • Collaborate cross-functionally to manage validation activities across the system lifecycle

What they're looking for

  • Manufacturing Execution Systems (MES) validation and Syncade experience
  • cGMP, GxP, GAMP, and 21 CFR Part 11 regulatory knowledge
  • Computer Systems Validation (CSV) methodologies and documentation
  • Electronic records and signatures (ER/ES) understanding
  • IT service management platforms (ServiceNow)
  • ERP systems (SAP, Oracle) and Electronic Batch Records (InfoBatch)
  • Technical and problem-solving skills with strong written and verbal communication
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Orion Innovation

Orion Innovation builds scalable web applications and AI-powered enterprise software solutions, with expertise in cloud-native database systems and GxP-compliant digital systems. The company is hiring full stack developers, sales professionals, database engineers, validation engineers, and support specialists to support its product development and market expansion efforts.

Industry
Technology & Software
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Likely interview questions

  • Describe your experience with Manufacturing Execution System validation, specifically with Syncade or similar platforms.
  • Walk us through your approach to developing a validation strategy using GAMP and risk-based methodologies for a computerized system.
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