Senior Manufacturing Engineer: IVD Automation & Scale-Up

LGC Limited; Traverse City (MI, MA); Remote; USD 120,000 - 150,000; Full time

Benefits offered by this job

25 days holidays

Life assurance & health allowance

Employee discounts

24/7 Employee Assistance Programme

Recognition schemes & monetary awards

Job summary

LGC Limited is seeking a Principal Manufacturing Engineer to lead high-impact scale-up and capacity projects in a regulated medical-device manufacturing environment. You will own CAPEX, automation, validation, and process refinement from concept through rollout, ensuring compliant and efficient operations.

This role requires strong cross-functional collaboration with Quality, Operations, and Finance to deliver reliable manufacturing solutions.

Qualifications

• Degree in Engineering (Manufacturing, Chemical, Mechanical, Biomedical, or related) or equivalent experience.
• Typically 10+ years in controlled manufacturing settings (IVD/medical devices preferred).
• Proven leadership of manufacturing scale-up, validation, and operational excellence.
• Strong knowledge of automation, controls, and project budgeting in regulated environments.
• Experience with commissioning, qualification, and validation documentation.

Responsibilities

• Lead manufacturing scale-up, capacity expansion, and efficiency improvement projects.
• Manage full lifecycle CAPEX, equipment, and automation initiatives from concept to operations.
• Provide technical leadership for validation activities across the project lifecycle.
• Support introduction of new products, methods, and equipment into QC manufacturing.
• Ensure activities align with IVD, ISO 13485, GMP, and internal Quality Systems.
• Collaborate with Operations, Quality, Engineering, Supply Chain, and Finance.
• Coach and mentor junior engineers and lead cross-functional project teams.

Skills

Manufacturing leadership

Scale-up expertise

CAPEX management

Validation & qualification

Cross-functional leadership

Automation & controls

Regulatory compliance

Project management

Problem solving

Education

Engineering degree

Job description

LGC Limited is seeking a Principal Manufacturing Engineer to lead high-impact scale-up and capacity projects in a regulated medical-device manufacturing environment. You will own CAPEX, automation, validation, and process refinement from concept through rollout, ensuring compliant and efficient operations.

This role requires strong cross-functional collaboration with Quality, Operations, and Finance to deliver reliable manufacturing solutions.