CQV Engineer

CQV Engineer

Process Equipment | Kaye Validator | Thermal Mapping

Role Overview

The CQV Engineer will plan, execute, and document commissioning and qualification activities for pharmaceutical process equipment, temperature-controlled units, and storage areas within a GMP-regulated environment.

The role combines hands-on equipment CQV with Kaye-based thermal mapping and requires close coordination with Engineering, Quality, Operations, Automation, Metrology, and vendors to deliver compliant and inspection-ready validation packages.

Key Responsibilities

• Plan and execute commissioning and qualification activities for pharmaceutical process equipment, skids, vessels, preparation and holding tanks, and associated process systems.

• Develop and review lifecycle documentation, including User Requirement Specifications (URS), risk assessments, design reviews, commissioning tests, IQ/OQ/PQ protocols, traceability matrices, and final reports.

• Verify equipment installation, instrumentation, calibration, alarms, interlocks, control sequences, operating ranges, and critical process parameters against approved requirements.

• Plan and execute temperature-mapping and qualification studies for freezers, incubators, cold rooms, and other temperature-controlled units.

• Set up, configure, operate, and troubleshoot Kaye Validator and associated data-acquisition equipment for thermal studies.

• Prepare, label, position, calibrate, and verify thermocouples or temperature sensors before and after study execution.

• Conduct empty and loaded mapping studies, including door-opening, power-failure, recovery, alarm, and other challenge tests where applicable.

• Review and analyse temperature data, identify hot and cold spots, evaluate excursions and recovery performance, and confirm compliance with approved acceptance criteria.

• Document and investigate discrepancies, deviations, failed tests, and atypical results. Support root-cause assessments, corrective actions, and timely closure.

• Coordinate field execution, system turnover, and documentation closure with equipment owners, vendors, and cross-functional stakeholders.

• Support change controls, periodic reviews, requalification planning, audit readiness, and ad hoc CQV activities while maintaining complete and traceable records.

Candidate Requirements

• Bachelor’s degree in Engineering, Life Sciences, Pharmaceutical Science, or a related discipline.

• Relevant CQV and process-equipment qualification experience within the pharmaceutical, biotechnology, or another GMP-regulated environment.

• Practical experience qualifying process equipment such as CIP/SIP skids, vessels, preparation or holding tanks, filtration, transfer, or comparable manufacturing systems.

• Hands-on experience using Kaye Validator or Kaye AVS for temperature mapping and thermal qualification studies.

• Practical experience qualifying freezers, incubators, cold rooms, or comparable temperature-controlled equipment and facilities.

• Good understanding of IQ/OQ/PQ execution, functional testing, sensor placement, calibration, data acquisition, deviations, and validation reporting.

• Able to interpret P&IDs, equipment specifications, engineering drawings, and vendor documentation. Familiarity with automated control systems would be advantageous.

• Working knowledge of GMP, Good Documentation Practices, data integrity, change control, and validation lifecycle requirements.

• Strong technical-writing, data-analysis, troubleshooting, planning, and stakeholder-management skills.