CQV Validation Lead for Automated Warehouse & ASRS (GMP)

CORE, a Unicon Company; Wilson (NC); On-site; USD 120,000 - 180,000; Full time

Job summary

CORE, a Unicon Company, is building an automated logistics facility and seeks a CQV professional to lead commissioning, qualification, and validation activities for ASRS and warehouse systems in a GMP-regulated environment.

The Validation SME will author and execute IQ, OQ, and PQ protocols, perform risk assessments, and develop traceability matrices, ensuring audit-ready documentation and compliance across all validation lifecycle stages.

Qualifications

• Bachelor's degree in Engineering or related technical discipline.
• 10+ years CQV experience in pharmaceutical, biotech, or medical device environments.
• Hands-on experience with ASRS and automated warehouse systems.
• Strong background authoring and executing IQ/OQ/PQ protocols for automated/robotic systems.
• Experience with WMS/WCS validation and system interface testing.
• Working knowledge of cGMP, 21 CFR Part 11, and GAMP 5.
• Strong technical writing skills for validation documentation (URS, FS, VSR, RTM)

Responsibilities

• Author, execute, and review IQ/OQ/PQ protocols for ASRS equipment, conveyance systems, robotics, and warehouse management/control systems (WMS/WCS)
• Develop and execute qualification strategies for automated storage, retrieval, and material handling equipment
• Partner with engineering, automation, and quality teams during the design phase to build a CQV plan that ensures qualification is uneventful and audit-ready
• Validate temperature, storage, and delivery conditions for materials moving through the ASRS, including scanning/verification systems used to confirm material integrity before use
• Perform risk assessments, gap analyses, and impact assessments related to ASRS design and automation integration
• Author and execute test protocols for point-to-point testing, alarm verification, and system interface qualification (WMS/WCS to ERP/MES)
• Support FAT/SAT activities for ASRS equipment and vendor-supplied automation systems
• Develop and maintain traceability matrices, URS, FS, and validation summary reports for the ASRS project
• Support change control, deviation investigation, and CAPA activities related to warehouse automation systems
• Ensure compliance with cGMP, 21 CFR Part 11, and GAMP 5 throughout the validation lifecycle

Skills

IQ/OQ/PQ protocols

ASRS

WMS/WCS validation

cGMP

21 CFR Part 11

GAMP 5

Education

Bachelor's degree in Engineering

Job description

CORE, a Unicon Company, is building an automated logistics facility and seeks a CQV professional to lead commissioning, qualification, and validation activities for ASRS and warehouse systems in a GMP-regulated environment.

The Validation SME will author and execute IQ, OQ, and PQ protocols, perform risk assessments, and develop traceability matrices, ensuring audit-ready documentation and compliance across all validation lifecycle stages.