CQV Engineer: GMP Validation & Commissioning Specialist

JMD Technologies Inc.

Bend (OR)

On-site

USD 110,000 - 117,000

Full time

23 hours ago
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Job summary

JMD Technologies Inc. is seeking an experienced CQV Engineer to support commissioning, qualification, and validation activities within a GMP-regulated environment.

The role focuses on qualification and validation of analytical instruments, computerized systems, and GMP equipment while ensuring GxP compliance and data integrity. The ideal candidate will perform IQ/OQ/PQ execution, CQV/CSV activities, validation documentation, and collaborate with Quality Control, Instrumentation, Engineering,

Qualifications

  • 3–5 years of CQV/CSV experience in a regulated industry.
  • IQ/OQ/PQ execution experience.
  • Experience qualifying analytical laboratory instruments and GMP equipment.
  • Knowledge of GMP/GxP, data integrity, and validation lifecycle requirements.
  • Experience supporting change controls, deviations, CAPAs, and impact assessments.
  • Familiarity with Kneat or similar validation/document management platforms.
  • Strong technical writing, documentation, organization, and communication skills.
  • Ability to work with cross-functional teams in a regulated environment.

Responsibilities

  • Support the qualification and validation of analytical laboratory instruments, computerized systems, and GMP equipment.
  • Develop, execute, review, and maintain validation lifecycle documentation.
  • Execute IQ, OQ, and PQ protocols and qualification activities.
  • Ensure calibration readiness, data integrity, and GMP compliance throughout qualification activities.
  • Collaborate with Quality Control, Instrumentation, Engineering, Automation, QA, and system owners.
  • Support change controls, impact assessments, deviations, CAPAs, and validation protocols.
  • Utilize Kneat for documentation, workflow, and validation activities.
  • Maintain inspection-ready documentation in accordance with GxP requirements.
  • Support Computerized System Validation (CSV) and CQV activities, including qualification execution and documentation.
  • Identify and resolve qualification/validation issues while maintaining project timelines.

Skills

CQV/CSV experience
IQ/OQ/PQ execution
Technical writing
Cross-functional collaboration

Tools

Kneat

Job description

JMD Technologies Inc. is seeking an experienced CQV Engineer to support commissioning, qualification, and validation activities within a GMP-regulated environment.

The role focuses on qualification and validation of analytical instruments, computerized systems, and GMP equipment while ensuring GxP compliance and data integrity. The ideal candidate will perform IQ/OQ/PQ execution, CQV/CSV activities, validation documentation, and collaborate with Quality Control, Instrumentation, Engineering,

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