Senior Manufacturing Engineer - Scale-Up & Validation

Lgc-Clinical-Diagnostics; Ballina; On-site; EUR 90,000 - 130,000; Full time

Benefits offered by this job

25 days holidays

Life assurance & health allowance

Discounts with local and nationalretai

Free 24/7 Employee AssistanceProgramme

Recognition schemes and monetaryAwards

Job summary

LGC Clinical Diagnostics seeks a Principal Manufacturing Engineer to lead scale-up and validation in a regulated medical device environment. You will drive major capital, equipment, automation, and process improvement projects from concept to rollout, ensuring compliant documentation and long-term performance.

You will collaborate across Operations, Quality, Engineering, and Finance, mentor junior engineers, and deliver reliable manufacturing solutions while maintaining ISO 13485 and GMP

Qualifications

• Degree in Engineering (Manufacturing, Chemical, Mechanical, Biomedical, or related) or equivalent experience.
• Typically, more than 10 years of experience in controlled manufacturing settings (IVD, diagnostics, Pharma, or medical devices preferred).
• Proven background in leading manufacturing scale-up, validation, and operational excellence in a regulated setting.
• Strong project management and delivery capabilities.
• Experience with validation, quality systems, regulatory adherence, and risk management.

Responsibilities

• Lead manufacturing scale-up, capacity increase, and projects to improve operational efficiency.
• Manage full lifecycle CAPEX, equipment, and automation projects from concept to operations.
• Provide technical leadership for validation activities across the project lifecycle.
• Supply senior-level engineering support for manufacturing workflows, equipment, and automation.
• Lead cross-functional projects from concept through implementation and handover.
• Resolve complex manufacturing, equipment, and quality issues with cross-functional teams.
• Support introduction of new products, methods, technologies, and equipment into QC manufacturing.
• Ensure engineering activities align with IVD, ISO 13485, GMP, and internal Quality Management Systems.

Skills

Manufacturing leadership

CAPEX project management

Validation expertise

Quality systems

Regulatory compliance

Cross-functional collaboration

Automation controls

Data-driven decisions

Mentoring engineers

Education

Engineering degree

Tools

Automation systems

Control systems

Job description

LGC Clinical Diagnostics seeks a Principal Manufacturing Engineer to lead scale-up and validation in a regulated medical device environment. You will drive major capital, equipment, automation, and process improvement projects from concept to rollout, ensuring compliant documentation and long-term performance.

You will collaborate across Operations, Quality, Engineering, and Finance, mentor junior engineers, and deliver reliable manufacturing solutions while maintaining ISO 13485 and GMP