Principal Manufacturing Engineer

LGC Group; Ballina; On-site; EUR 120,000 - 160,000; Full time

Benefits offered by this job

25 days holidays

Life assurance & health allowance

Retail discounts

24/7 Employee Assistance Programme

Recognition schemes

Long-term career opportunities

Job summary

LGC Group is seeking a Principal Manufacturing Engineer to lead and innovate within a regulated medical device manufacturing environment. You will drive scale-up, validation strategies, capacity expansion, and operational improvements while providing technical leadership across functions.

This role oversees capital projects from concept through budgeting, installation, qualification, and handover to operations, ensuring compliance with 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 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

Project management

Validation

Regulatory compliance

Risk management

Documentation

Automation integration

Control systems

Data-driven decisions

Education

Engineering degree

Job description

Job Description

Position Summary

The Principal Manufacturing Engineer role at LGC presents a unique and exhilarating opportunity to lead and innovate within a top-tier medical device manufacturing environment! As a seasoned technical leader, you will manage manufacturing scale-up projects, validation approaches, capacity expansion, and operational advancement initiatives. This position offers strategic engineering leadership and overall responsibility for major capital, equipment, automation, and process refinement projects, steering them from concept through development, budgeting, validation, rollout, documentation, and long-term performance. Our supportive environment encourages you to provide reliable, compliant, and effective manufacturing solutions while working collaboratively across functions.

• 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.

Qualifications Knowledge, Experience, Skills, and Certifications

Essential Knowledge & 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.

Behavioural & Interpersonal Proficiencies:

• Known as a reliable senior engineer with demonstrated success in managing complex projects within a regulated manufacturing environment.
• Operates with a high degree of ownership for assigned projects and workstreams.
• Influences decisions through experience, data, and collaboration.
• Passionate about practical execution, continuous improvement, and balanced results.

Additional Information

LGC is a top life science tools company, offering important solutions in growing markets.

Benefits

• 25 days holidays
• Life assurance & health allowance
• Discounts with local and national retailers
• Free 24/7 Employee Assistance Programme
• Recognition schemes and monetary awards
• Great long-term career opportunities

At LGC, we foster a culture of inclusion and collaboration.

We believe that diverse perspectives lead to better outcomes and encourage applicants from all backgrounds to apply.

We are an equal opportunity employer and offer reasonable accommodations to individuals with disabilities.

If you require any adjustments throughout the recruitment process, please let us know.

Join us in this unique opportunity to be part of a company that is leading advancements in the industry!