Lead Process Engineer, IVD Manufacturing Excellence

LGC Group; Ballina; On-site; EUR 90,000 - 130,000; Full time

Benefits offered by this job

25 days holidays

Life assurance

Employee discounts

EAP access

Recognition schemes

Career opportunities

Job summary

LGC Group is seeking a Principal Process Engineer to serve as the site technical lead for current-state process performance in regulated IVD manufacturing. You will be accountable for process capability, control, and continuous-improvement initiatives within Quality and Validation frameworks.

The role also supports expansion, validation, tech transfer and new product introductions. You will work with Operations, Quality, Validation, Engineering and Supply Chain, driving problem-solving and

Qualifications

• Degree in Engineering, Science, Manufacturing, Chemical, Mechanical, Biomedical or related discipline.
• Typically 10+ years in regulated medical device/IVD/pharma manufacturing.
• Proven leadership in process engineering, validation and Operational Excellence.
• Strong knowledge of Shingo, Lean Six Sigma, standard work, and value-stream improvements.
• Experience with SPC, process capability, MSA, DOE and hypothesis testing.
• Knowledge of commissioning IQ/OQ/PQ, ISO 13485 and GMP documentation.

Responsibilities

• Provide site process engineering leadership for current-state performance in regulated IVD manufacturing.
• Lead process capability, control, and continuous improvement initiatives to improve yield and right-first-time metrics.
• Support validation, new product introduction, technology transfer, and capital expansion projects.
• Collaborate with Operations, Quality, Validation, Engineering, Supply Chain, Finance and Regulatory teams.
• Prepare technical assessments, risk evaluations and validation documentation for stakeholders.
• Coach engineers and cross-functional teams in statistical methods and Operational Excellence.
• Maintain process flows, P&IDs and process-control documentation and assist in deviations closure.

Skills

Shingo principles

Lean Six Sigma

Standard work

Value-stream improvement

Statistical problem solving

Process capability

SPC & MSA

DOE & hypothesis testing

Regulated manufacturing experience

Education

Engineering or related technical degree

Tools

Statistical software

Job description

LGC Group is seeking a Principal Process Engineer to serve as the site technical lead for current-state process performance in regulated IVD manufacturing. You will be accountable for process capability, control, and continuous-improvement initiatives within Quality and Validation frameworks.

The role also supports expansion, validation, tech transfer and new product introductions. You will work with Operations, Quality, Validation, Engineering and Supply Chain, driving problem-solving and