Principal Manufacturing Engineer

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, Sera Care 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.

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.

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.
• Known as a reliable…