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 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.

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.

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.

Preferred Qualifications:

• 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.

Work Methodology:

• 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.