CQV Specialist

CIS International•Arizona, AZ

8d•Onsite

About The Position

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 environment. This is a short-term engagement focused on Performance Qualification (PQ) activities scheduled for July 2026, with potential involvement in process and cleaning validation projects.

Requirements

Bachelor's degree in Engineering, Life Sciences, Biotechnology, or related discipline.
3–10 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.
Required language: English -oral and written.

Nice To Haves

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.

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.