Validation SME

Shoolin Inc; North Carolina; On-site; USD 110,000 - 170,000; Full time

Job summary

Shoolin Inc is seeking an experienced Validation SME to support a fully automated GMP-regulated warehouse facility in Wilson, NC. The role focuses on CQV, ASRS, automated storage, and material handling validation.

The ideal candidate has 10+ years of CQV/validation in pharma/biotech/medical device environments, with hands-on IQ/OQ/PQ, WMS/WCS validation, and strong technical writing skills to develop URS, FS, RTM and VSR documentation.

Qualifications

• Bachelor's degree in Engineering or related technical discipline.
• 10+ years CQV/Validation experience in pharma/biotech/medical device environments.
• Hands-on with ASRS, automated warehouses or large-scale material handling systems.
• Strong experience authoring and executing IQ/OQ/PQ protocols.
• Experience with WMS/WCS validation and system integration testing.
• Knowledge of cGMP, 21 CFR Part 11 and GAMP 5.
• Strong technical writing and validation documentation.

Responsibilities

• Author, execute, and review IQ/OQ/PQ for ASRS, conveyors, robotics, and warehouse systems.
• Develop and execute qualification strategies for automated storage and material handling equipment.
• Support WMS/WCS validation and interface testing with ERP/MES.
• Perform risk assessments, gap analyses, and impact assessments.
• Execute point-to-point testing, alarm verification, and automation interface qualification.
• Support FAT/SAT activities for ASRS equipment and vendor systems.
• Develop and maintain URS, FS, RTM, and Validation Summary Reports.
• Support change controls, deviations, and CAPA related to warehouse automation.
• Ensure compliance with cGMP, 21 CFR Part 11, and GAMP 5.

Skills

CQV validation

ASRS validation

Automated warehouse

WMS/WCS validation

Interface testing

GAMP 5 knowledge

21 CFR Part 11 knowledge

Technical writing

Education

Bachelor’s degree in Engineering or related technical discipline

Job description

We’re Hiring: Validation SME – ASRS / Warehouse Validation

Location: Wilson, NC

Duration: Long-Term Contract

Experience: 10+ Years

Industry: Pharmaceutical / Biotech / Medical Device

We are seeking an experienced Validation SME to support a new, fully automated GMP-regulated logistics and warehouse facility in Wilson, NC. The ideal candidate will have strong hands‑on CQV, ASRS, automated warehouse, and material handling validation experience.

Key Responsibilities:

• Author, execute, and review IQ/OQ/PQ protocols for ASRS, conveyance systems, robotics, and automated warehouse systems
• Develop and execute qualification strategies for automated storage, retrieval, and material handling equipment
• Support WMS/WCS validation and system interface testing with ERP/MES
• Perform risk assessments, gap analyses, and impact assessments
• Execute point‑to‑point testing, alarm verification, and automation interface qualification
• Support FAT/SAT activities for ASRS equipment and vendor automation systems
• Develop and maintain URS, FS, RTM, and Validation Summary Reports (VSR)
• Support change controls, deviations, and CAPA activities related to warehouse automation
• Ensure compliance with cGMP, 21 CFR Part 11, and GAMP 5

Required Qualifications:

• Bachelor’s degree in Engineering or a related technical discipline
• 10+ years of CQV/Validation experience in pharmaceutical, biotech, or medical device environments
• Hands‑on experience with ASRS, automated warehouses, or large‑scale material handling systems
• Strong experience authoring and executing IQ/OQ/PQ protocols
• Experience with WMS/WCS validation and system integration testing
• Knowledge of cGMP, 21 CFR Part 11, and GAMP 5
• Strong technical writing and validation documentation experience