Senior Manufacturing Engineering Leader, IVD Scale-Up

LGC

Ballina

On-site

EUR 100,000 - 150,000

Full time

29 hours ago
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Benefits offered by this job

25 days holidays
Life assurance & health allowance
Discounts with retailers
EAP – 24/7 support

Job summary

LGC is seeking a Principal Manufacturing Engineer to lead scale-up and validation initiatives within its medical device manufacturing environment in Ireland. You will drive capacity expansion, automation improvements, and compliant processes across cross-functional teams, ensuring robust documentation and adherence to ISO 13485/GMP standards.

You will provide senior technical leadership, mentor engineers, and manage projects from concept through rollout, budgeting, and long-term performance

Qualifications

  • Degree in Engineering (Manufacturing, Chemical, Mechanical, Biomedical, or related) or equivalent experience.
  • Typically, 10+ years in controlled manufacturing settings (IVD/Pharma/medical devices).
  • Proven leadership of large-scale manufacturing, validation, and operational excellence in regulated environments.
  • Strong validation, quality systems, regulatory adherence, and risk management knowledge.

Responsibilities

  • Lead manufacturing scale-up, capacity increases, and operational efficiency projects.
  • Manage full lifecycle CAPEX, equipment, and automation initiatives with budgeting and vendor management.
  • Provide technical leadership for validation activities: IQ/OQ/PQ, protocol development, and documentation.
  • Support commissioning, installation, qualification, validation, and handover to operations.
  • Coordinate cross-functional teams across Operations, Quality, Engineering, and Finance.
  • Mentor junior engineers and provide day-to-day technical leadership.

Skills

Engineering degree
10+ years exp
Regulated manufacturing
Validation expertise
Project management
Automation controls
Documentation skills
Cross-functional leadership

Education

Engineering degree

Tools

Control systems
Automation equipment
IQ/OQ/PQ protocols

Job description

LGC is seeking a Principal Manufacturing Engineer to lead scale-up and validation initiatives within its medical device manufacturing environment in Ireland. You will drive capacity expansion, automation improvements, and compliant processes across cross-functional teams, ensuring robust documentation and adherence to ISO 13485/GMP standards.

You will provide senior technical leadership, mentor engineers, and manage projects from concept through rollout, budgeting, and long-term performance

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