Senior Manufacturing Engineer - Scale-Up & Validation

LGC; Ballina; On-site; EUR 90,000 - 130,000; Full time

Benefits offered by this job

25 days holidays

Life assurance & health allowance

Discounts with retailers

24/7 Employee Assistance Programme

Recognition schemes

Job summary

LGC Clinical Diagnostics seeks a Principal Manufacturing Engineer to lead scale-up and capital projects in a top-tier medical device environment. You will guide validation strategies, drive capacity expansion, and oversee automation initiatives from concept to rollout, ensuring compliance and performance.

You will provide technical leadership across manufacturing workflows, collaborate with Quality, Operations, and Finance, and mentor junior engineers while delivering reliable manufacturing

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 extensive manufacturing, scale-up, validation, and operational excellence efforts within a regulated setting, complemented by strong project management and delivery capabilities.
• Extensive experience in validation, quality systems, regulatory adherence, and risk management, along with solid practical knowledge of commissioning and qualification criteria in regulated manufacturing.
• Strong knowledge of automation, equipment integration, and control systems, with experience managing project costs, budgets, and value delivery within regulated manufacturing projects.
• Recognized ability to solve novel, high-complexity technical problems.
• Strong technical documentation, communication, and data-driven decision-making skills, with experience preparing and reviewing project, validation, and engineering documentation.

Responsibilities

• Lead manufacturing scale-up, capacity increase, and projects aimed at improving operational efficiency within manufacturing.
• Manage full lifecycle CAPEX, equipment, and automation projects, encompassing case development, budgeting, cost tracking, user requirements, build review, vendor management, installation, qualification, validation, start-up, and transition to operations.
• Provide technical leadership for validation activities across the full project lifecycle, including commissioning, IQ, OQ, PQ, protocol development, execution oversight, deviation resolution, final validation closure, and preparation or review of compliant project and validation documentation.
• Supply senior-level engineering support for manufacturing workflows, equipment, and automation systems, applying solid technical skills in automated equipment, controls integration, and potential process improvements.
• Lead complex cross-functional projects from concept through implementation and ongoing operational handover, taking clear responsibility for scope, schedules, risks, resources, collaborators, change control, and deliverables.
• Lead resolution of complex manufacturing, equipment, and quality issues in collaboration 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.
• Partner effectively with Operations, Quality, Engineering, Supply Chain, and Finance collaborators.
• Coach and mentor junior engineers and provide day-to-day technical leadership within project teams.

Skills

Scale-up leadership

CAPEX management

Automation integration

Validation leadership

Cross-functional collaboration

Quality systems

Regulatory compliance

Project management

Equipment commissioning

Education

Engineering degree

Job description

LGC Clinical Diagnostics seeks a Principal Manufacturing Engineer to lead scale-up and capital projects in a top-tier medical device environment. You will guide validation strategies, drive capacity expansion, and oversee automation initiatives from concept to rollout, ensuring compliance and performance.

You will provide technical leadership across manufacturing workflows, collaborate with Quality, Operations, and Finance, and mentor junior engineers while delivering reliable manufacturing