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CQV Specialist
Job Location:
Job Location:
Arizona, AZ - USA
Monthly Salary:
Not provided by the employer
Monthly Salary:
Posted:
28 June 2026 (30+ days ago)
Posted:
Application Deadline:
25 September 2026
Application Deadline:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
Summary:
Seeking a competent junior-to-mid-level Commissioning Qualification and Validation Specialist (CQV) to support upcoming Qualification and Validation activities. This contractor will play a key role in reviewing and executing qualification documentation supporting manufacturing equipment qualification and contributing to validation activities in a regulated GxP is a short-term engagement focused on Performance Qualification (PQ) activities scheduled for July 2026 with potential involvement in process and cleaning validation projects.
Responsibilities:
Seeking a competent junior-to-mid-level Commissioning Qualification and Validation Specialist (CQV) to support upcoming Qualification and Validation activities. This contractor will play a key role in reviewing and executing qualification documentation supporting manufacturing equipment qualification and contributing to validation activities in a regulated GxP is a short-term engagement focused on Performance Qualification (PQ) activities scheduled for July 2026 with potential involvement in process and cleaning validation projects.
Responsibilities:
- Support commissioning qualification and validation activities for a new GMP facility and manufacturing areas.
- Author review and execute validation deliverables including MVPs Validation Plans IQ/OQ/PQ protocols traceability matrices and validation summary reports.
- Perform cleanroom qualification activities including airflow visualization room recovery testing differential pressure verification and environmental monitoring support.
- Execute qualification activities for autoclaves parts washers glassware washers CTUs process equipment and associated utility systems.
- Perform temperature mapping studies for refrigerators freezers incubators stability chambers warehouses and other controlled temperature storage areas.
- Support qualification of facility and utility systems including HVAC WFI clean steam compressed gases and other GMP utilities.
- Investigate protocol deviations discrepancies and validation issues; support impact assessments root cause investigations and CAPA activities.
- Review revise and author SOPs work instructions and other controlled GMP documentation to support startup and operational readiness.
- Work closely with Engineering Facilities Quality Manufacturing and vendors to support project timelines and qualification activities.
- Support change controls commissioning turnover packages punch list resolution and validation lifecycle activities as required.
- Ensure all qualification and validation activities are performed in accordance with GMP requirements site procedures and project schedules.
- Bachelors degree in Engineering Life Sciences Biotechnology or related discipline.
- 310 years of experience in CQV Validation or Pharmaceutical Manufacturing environments.
- Hands-on experience with equipment qualification (IQ/OQ/PQ) in regulated GMP facilities.
- Experience qualifying manufacturing equipment autoclaves washers filling systems and laboratory equipment.
- Knowledge of temperature mapping and qualification methodologies.
- Understanding of GxP regulations and validation lifecycle principles.
- Experience reviewing and approving validation documentation and SOPs.
- Strong technical writing and execution skills.
- Experience in both sterile and non-sterile pharmaceutical manufacturing environments.
- Familiarity with Validation Master Plans (VMPs).
- Process Validation experience.
- Cleaning Validation experience.
- Previous consulting or project-based validation experience preferred.
- Professional services contract.
- Full time job.
- 8-12 weeks of assignment with potential extension.
- Full on-site job in Arizona US.
- Type of industry: Pharmaceuticals
- All inclusive rate - the contractor will receive a pay per hour to cover labor and expenses.
- Required language: English -oral and written.
- Expected hiring month: July 2026.
Required Experience:
IC
