Contract Automation Project Engineer - Multi-Line FAT & SI

Morgan McKinley; Cork; Hybrid; EUR 83,000 - 110,000; Full time

Job summary

Morgan McKinley in Cork, Ireland, is seeking an experienced Senior Automation Engineer/Project Engineer for a 12-month contract (likely extension). Hybrid work: 3 days onsite, 2 days from home.

You will own design, vendor build, FAT/SAT, and validation setup for 7–8 complex automated production lines across global sites. The role requires 5+ years in medical devices automation, hands-on machine builds, vendor management, and international travel for FATs/build milestones.

Qualifications

• Minimum 5 years of hands-on automation delivery within Medical Devices.
• Experience bringing bespoke automated machinery from design concepts through build oversight, FAT, installation, and handover.
• Experience holding vendors to specifications, budget, and delivery schedules.
• Knowledge of GAMP, ISO 13485, and statistical tools used for machine qualification.
• Willingness to travel internationally for equipment FATs and build milestones.

Responsibilities

• Vendor management and build oversight for machine vendors and integrators worldwide.
• Lead systems integration across vision, robotics, multi-axis motion, PLCs/HMIs, and high-speed assembly.
• Oversee process capability, cycle-time optimization, and GR&R/MSA ahead of validation.
• Develop IQ/OQ/PQ protocols under ISO 13485/FDA to enable formal validation.
• Travel internationally during FATs and build milestones to sign off equipment.

Skills

Vendor management

Systems integration

Process capability

Validation setup

Global delivery

Tools

PLC/HMI

GR&R

MSA

Job description

Location: Cork, Ireland

Hybrid: 3 days onsite, 2 days from home

Rate: Circa €70/hr (DOE)

Duration: 12 Month Contract - strong chance of extension

Travel Requirements: FAT & Build oversight across Scotland, the US, Malaysia, and other international vendor sites.

The Context & Scope

We are supporting a major medical device manufacturer expanding their Cork site. The project involves taking ownership of the design, vendor build, FAT/SAT, and validation setup for 7 to 8 complex, automated production lines handling diverse product streams.

This is an end-to-end delivery role. You will manage the external equipment integrators, oversee machine builds, prove out process capability, and prepare the assets for site validation and handover.

This is the ideal next step for a Senior Automation Engineer or a Project Engineer ready to advance into global delivery. Designed for someone who built their foundation in hands on technical execution, managing machine builds and vendor interactions, this role offers the opportunity to step up into a fully project-focused, global project leadership position.

You will sit at the center of the project: managing external equipment integrators, overseeing machine builds globally, proving out process capability, and driving handover into validation.

Core Responsibilities

• Vendor Management & Build Oversight: Serve as the primary technical interface for machine builders and integrators globally. Drive design reviews, risk assessments, FATs, and SATs.
• Systems Integration: Lead technical execution across machine vision, robotics, multi-axis servo motion, PLCs/HMIs, and high-speed mechanical assembly.
• Process Characterisation: Oversee process capability, cycle-time optimization, and statistical characterisation (GR&R, MSA) ahead of validation.
• Validation Setup: Develop user requirements, equipment specs, and test protocols to ensure equipment seamlessly enters formal IQ/OQ/PQ under ISO 13485 / FDA regulations.
• Global Delivery: Travel extensively during equipment build and FAT stages (US, Europe, Asia) to troubleshoot, sign off, and clear equipment for shipment.

Technical Profile Required

• Minimum 5 years of hands-on automation delivery within Medical Devices
• Proven background bringing bespoke automated machinery from initial vendor design concepts through build oversight, FAT, installation, and process handover.
• Solid background holding vendors accountable to technical specifications, budget, and delivery schedules.
• Strong working knowledge of GAMP, ISO 13485, and statistical tools used for machine qualification.
• Willingness to travel internationally for equipment FATs and build milestones.