Validation Engineer

HRM Search Partners; Ireland; On-site; EUR 70,000 - 110,000; Full time

Job summary

HRM Search Partners seeks an experienced Validation Lead to oversee end-to-end validation for a fleet of AGVs in a GMP manufacturing and cleanroom logistics environment. You will bridge automation vendor capabilities with site compliance, ensuring robust, auditable validation results.

Responsibilities include FAT/SAT, IQ/OQ/PQ, CSV, safety validation, and MES/WMS interfaces per 21 CFR Part 11 and EU Annex 11, with collaboration across QA, Automation, Facilities, and Operations.

Qualifications

• Bachelor's degree in Mechanical/Automation Engineering or related field.
• 3–5+ years validation experience in regulated Life Sciences.
• Proven track record with AGVs/AMRs and automated equipment.

Responsibilities

• Author and execute full validation deliverables for AGV hardware/software (VP, URS, FS, IQ/OQ/PQ, VSR).
• Coordinate FAT/SAT with vendors; ensure docs meet cGMP and GAMP 5.
• Lead validation of FMS interfaces with MES/WMS and controls per 21 CFR Part 11 / Annex 11.
• Validate AGV safety: LiDAR, collision avoidance, E-stops, docking, charging.
• Validate operation in ISO 7/Grade C/D cleanrooms and containment protocols.
• Collaborate with QA, Automation, Facilities, Warehousing, Operations on milestones.
• Lead RCIs for deviations; write deviation reports and CAPAs.

Skills

Validation

cGMP

GAMP 5

21 CFR Part 11

ALCOA+ Data Integrity

Software Testing

Stakeholder Mgmt

Audit Documentation

CSV

Education

Bachelor's degree in Mechanical/Automation Engineering or related field

Tools

MES/WMS Systems

Job description

In this role, you will lead the Validation for a new fleet of Automated Guided Vehicles (AGVs) introduced to our GMP manufacturing and cleanroom logistics environment.

You will oversee end-to-end validation - from initial design review and vendor FAT/SAT through to IQ/OQ/PQ execution, safety system verification, and computer systems validation (CSV) for fleet management software. As the technical subject matter expert (SME), you will bridge automation vendor capabilities with site compliance requirements, ensuring a seamless, compliant, and robust autonomous material handling operation.

Responsibilities

• Author, review, and execute full-lifecycle validation deliverables for AGV hardware and software, including Validation Plans (VP), User Requirement Specifications (URS), Functional Specifications (FS), Risk Assessments (FMEA), IQ/OQ/PQ protocols, and Validation Summary Reports (VSR).
• Partner with AGV equipment manufacturers and systems integrators during Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT). Ensure vendor testing documentation aligns with cGMP and GAMP 5 standards.
• Lead the validation of AGV Fleet Management Systems (FMS), navigation software, and software interfaces with site MES (Manufacturing Execution System), WMS (Warehouse Management System), and automated door/elevator controllers in compliance with 21 CFR Part 11 and EU Annex 11.
• Validate AGV safety mechanisms, including optical LiDAR sensors, collision avoidance bumpers, emergency stops, path navigation accuracy, payload docking, and automated battery charging stations.
• Validate AGV performance within classified cleanroom environments (ISO 7 / Grade C/D), ensuring cleanroom particle generation standards, material transfer airlock interlocks, and containment protocols are fully maintained.
• Coordinate with Quality Assurance, Automation Engineering, Facilities/EHS, Warehousing, and Operations to ensure project milestones align with site change control protocols.
• Lead root-cause investigations for protocol deviations or non-conformances identified during testing; author formal deviation reports and establish CAPAs.

Experience

• Bachelor's degree in Mechanical Engineering, Electrical/Automation Engineering, Mechatronics, Biomedical Engineering, or a related scientific discipline.
• 3-5+ years of direct validation experience within a regulated Life Sciences environment (Pharmaceutical, Biotech, or Medical Devices).
• Proven track record validating automated material handling systems, robotics, AGVs, AMRs (Autonomous Mobile Robots), or complex automated manufacturing equipment.
• Deep understanding of cGMP regulations, GAMP 5 guidelines, FDA 21 CFR Part 11, EU Annex 11, and ISO cleanroom standards.
• Solid background in CSV methodologies, ALCOA+ data integrity principles, and software interface integration testing.
• Strong experience authoring clear, audit-ready validation protocol packages and summary reports.
• Excellent stakeholder management and cross-functional project execution skills in a fast-paced environment.