Lead Manufacturing Engineer - IVD Scale-Up & Validation

SeraCare Clinical Diagnostics; Ballina; Sur place; EUR 90 000 - 130 000; Plein temps

Avantages offerts par ce poste

25 days holidays

Life assurance & health allowance

Discounts with local retailers

Free 24/7 Employee Assistance Program

Recognition schemes and monetaryAwards

Great long-term career opportunities

Résumé du poste

LGC Clinical Diagnostics in Ballina, Ireland seeks an experienced Principal Manufacturing Engineer to lead scale-up, validation, and operational improvements in a regulated medical device environment. You will manage capital projects, drive automation, ensure QMS alignment, and collaborate across Operations, Quality, Engineering, and Finance to deliver reliable manufacturing solutions.

You will coach engineers, own project scopes, schedules, risks, and deliverables, and contribute to continuous

Qualifications

• Extensive experience leading manufacturing scale-up, validation, and operational excellence in regulated settings.
• Strong project management, budgeting, and delivery capabilities.
• Solid knowledge of commissioning and qualification criteria in regulated manufacturing.

Responsabilités

• Lead manufacturing scale-up, capacity expansion, and projects to improve efficiency.
• Manage full lifecycle CAPEX, equipment, and automation projects with budgeting and vendor mgmt.
• Provide technical leadership for validation across the project lifecycle (IQ/OQ/PQ).
• Support introduction of new products, methods, and equipment into QC manufacturing.
• Ensure alignment with IVD, ISO 13485, GMP, and internal QMS.
• Coach and mentor junior engineers and lead cross-functional teams.

Connaissances

Manufacturing leadership

CAPEX management

Validation (IQ/OQ/PQ)

Automation integration

Cross-functional leadership

Regulatory compliance

Project management

Documentation & reporting

Budgeting & cost control

IVD/regulated manufacturing

Formation

Engineering degree (Manufacturing/Mechanical/Biomedical)

10+ years in controlled manufacturing

Description du poste

LGC Clinical Diagnostics in Ballina, Ireland seeks an experienced Principal Manufacturing Engineer to lead scale-up, validation, and operational improvements in a regulated medical device environment. You will manage capital projects, drive automation, ensure QMS alignment, and collaborate across Operations, Quality, Engineering, and Finance to deliver reliable manufacturing solutions.

You will coach engineers, own project scopes, schedules, risks, and deliverables, and contribute to continuous