Validation Engineer - GMP AGV Fleet (CSV)

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

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.