Senior Process Engineer, IVD Manufacturing Excellence

LGC; Ballina; On-site; EUR 95,000 - 130,000; Full time

Benefits offered by this job

25 days holidays

Life assurance & health allowance

Discounts with retailers

Employee Assistance Programme

Career development opportunities

Job summary

LGC is seeking a Principal Process Engineer to act as the site technical lead for current-state process performance in regulated IVD manufacturing. You will drive process capability, yield and right‑first‑time improvements while supporting validation, tech transfer and NPI.

This individual contributor role emphasizes technical leadership, mentorship of engineers, and collaboration with Operations, Quality, Validation and Regulatory teams to ensure compliant, efficient processes.

Qualifications

• Degree in Engineering, Science, Manufacturing, Chemical, Mechanical, Biomedical, Process Engineering or related.
• Typically 10+ years in regulated medical device, diagnostics, IVD, pharmaceutical or life sciences manufacturing.
• Proven leadership in process engineering, validation and Operational Excellence in regulated environments.
• Strong knowledge of Shingo, Lean Six Sigma, standard work, VSM and daily management.
• Demonstrated capability in SPC, process capability, MSA, DOE and hypothesis testing.

Responsibilities

• Lead site-wide structured problem solving for deviations and performance issues using DMAIC, A3, 5 Why, Ishikawa and FMEA.
• Drive process characterisation, validation, technology transfer and new product introduction.
• Coach cross‑functional teams in statistical methods and Operational Excellence practices.
• Maintain process flows, P&IDs, control documentation and readiness for validation.

Skills

Shingo principles

Lean Six Sigma

Statistical problem solving

Process control

GMP / ISO 13485 knowledge

Education

Engineering degree or related technical discipline

10+ years in regulated medical device/pharma/manufacturing

Tools

SPC

MSA

DOE

Hypothesis testing

Value-stream mapping

Job description

LGC is seeking a Principal Process Engineer to act as the site technical lead for current-state process performance in regulated IVD manufacturing. You will drive process capability, yield and right‑first‑time improvements while supporting validation, tech transfer and NPI.

This individual contributor role emphasizes technical leadership, mentorship of engineers, and collaboration with Operations, Quality, Validation and Regulatory teams to ensure compliant, efficient processes.