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.