Senior Manufacturing Engineer – Medical Devices & Scale-Up

SeraCare Clinical Diagnostics

Ballina

On-site

EUR 90,000 - 130,000

Full time

14 days+

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Benefits offered by this job

25 days holidays

Life assurance

Health allowance

Discounts with retailers

24/7 Employee Assistance Programme

Job summary

LGC Clinical Diagnostics is seeking a Principal Manufacturing Engineer to lead scale-up, validation, and capital projects in a regulated medical-device manufacturing environment. You will drive operational excellence, oversee automation initiatives, and collaborate across functions to deliver reliable manufacturing solutions.

The role emphasizes IQ/OQ/PQ validation, cross-functional leadership, and a strong commitment to quality systems and regulatory compliance.

Qualifications

Degree in Engineering or related field.
10+ years in controlled manufacturing settings (IVD/medical devices preferred).
Experience leading scale-up, validation, and operational excellence in regulated manufacturing.
Strong knowledge of validation, quality systems, and regulatory compliance.

Responsibilities

Lead scale-up, capacity expansion, and efficiency projects in manufacturing.
Manage full lifecycle CAPEX, equipment, and automation initiatives.
Provide technical leadership for validation (IQ/OQ/PQ) and documentation.
Support manufacturing workflows, controls integration, and process improvements.
Oversee cross-functional projects from concept to handover and sustainment.
Resolve complex manufacturing, equipment, and quality issues with teams.
Assist introduction of new products and technologies into QC manufacturing.
Ensure activities align with IVD, ISO 13485, GMP and QMS.