Validation SME – ASRS (Automated Storage & Retrieval Systems) / Warehouse Validation

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

Our client is building a fully automated logistics/warehouse facility as part of a new campus expansion, supporting storage and retrieval of raw materials and finished goods in a GMP-regulated environment. We're seeking an experienced CQV professional to lead commissioning, qualification, and validation activities for the ASRS and associated automated warehouse systems.

Position Summary

The Validation SME will be responsible for authoring and executing IQ, OQ, and PQ protocols for ASRS equipment and automated warehouse systems, ensuring the facility design and qualification approach support a smooth GMP review and inspection-ready state. This is a heavy hands-on CQV role requiring strong warehouse/automated logistics experience in addition to traditional GMP equipment validation background.

Key Responsibilities

• Author, execute, and review IQ, OQ, and 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 supporting raw material and finished goods flow
• 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

Required Qualifications

• Bachelor's degree in Engineering or related technical discipline
• 10+ years of CQV experience in pharmaceutical, biotech, or medical device manufacturing environments
• Hands-on experience with ASRS, automated warehouse systems, or large-scale material handling/logistics equipment qualification
• 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)