Principal Manufacturing Engineer

SeraCare 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 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.

Skills

Manufacturing leadership

Automation

Validation

Project management

Quality systems

Regulatory adherence

Documentation & data

Cross-functional collaboration

Education

Engineering degree

Job description

Company Description

LGC Clinical Diagnostics develops and manufactures a range of diagnostic quality solutions and component materials for the life sciences industry. We partner with IVD assay developers, and pharmaceutical, CRO and academic institutions in commercialisation activities across the entire diagnostic pipeline. Laboratorians and diagnostic professionals rely on LGC’s products to support accurate and reliable diagnostic results.

Company Description

LGC Clinical Diagnostics develops and manufactures a range of diagnostic quality solutions and component materials for the life sciences industry. We partner with IVD assay developers, and pharmaceutical, CRO and academic institutions in commercialisation activities across the entire diagnostic pipeline. Laboratorians and diagnostic professionals rely on LGC’s products to support accurate and reliable diagnostic results. Our operating entities include Maine Standards Company, SeraCare Life Sciences, and Technopath Clinical Diagnostics, which are in vitro diagnostics (IVD) manufacturers of quality measurement tools (calibrators, controls, linearity, EQA/PT, biological materials), the Native Antigen Company, which is a manufacturer and supplier of viral antigens and LGC Proficiency Testing a global leader in PT schemes. We operate FDA-registered and ISO 13485-accredited facilities in Maine (USA), Massachusetts (USA), Maryland (USA), Tipperary (Ireland), ISO 9001-accredited facility in Oxford, UK, and Traverse City, Michigan US. Our exceptional team, scientific skills, operational efficiency, and high-quality systems are primed daily to assist various advanced technologies, benefiting patient outcomes.

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.

To perform this job successfully, an individual must be able to perform each of the following essential functions satisfactorily:

• 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

• 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.

Our values

• PASSION
• CURIOSITY
• INTEGRITY
• BRILLIANCE
• RESPECT

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!

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