CQV Engineer – Commissioning, Qualification & Validation

Employment Type: Contract

Duration: 9 Months

Status: Accepting Candidates

We are seeking an experienced CQV Engineer to support commissioning, qualification, and validation activities within a regulated GMP environment. This role will focus on the qualification and validation of analytical laboratory instruments, computerized systems, and GMP equipment while ensuring compliance with GxP, data integrity, and validation lifecycle requirements
.

The ideal candidate will have hands‑on experience with IQ/OQ/PQ execution, CQV/CSV activities, validation documentation, and GMP-regulated environments
, along with strong technical writing and cross‑functional collaboration skills.

• 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 the Kneat validation platform 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.

• 3-5 years of CQV and/or CSV experience in a regulated industry preferred.
• Hands‑on experience with IQ, OQ, and PQ execution.
• Experience qualifying analytical laboratory instruments and GMP equipment preferred.
• 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, communication, and problem‑solving skills.
• Ability to work effectively with cross‑functional teams in a regulated environment.

• Estimated hourly range: $80.00-$85.00/hr (W-2).
• Final rate within this range will be based on skills, experience, and interview results.