Senior Process Engineer, IVD Quality & Efficiency

LGC Limited; Maryland; Remote; USD 150,000 - 190,000; Full time

Benefits offered by this job

25 days holidays

Life assurance & health allowance

Employee Assistance Programme

Job summary

LGC Limited in Maryland, USA seeks a Principal Process Engineer to serve as the site technical lead for current-state process performance in regulated IVD quality-control manufacturing. The role drives BAU process engineering support, process capability, validation and technology transfer.

You will collaborate with Operations, Quality, Validation, Engineering, Supply Chain and Regulatory, providing technical leadership, coaching and data-driven problem solving.

Qualifications

• Bachelor's degree in Engineering or related technical discipline.
• Typically 10+ years of experience in regulated medical device, diagnostics, IVD, pharmaceutical or life sciences manufacturing.
• Proven leadership in BAU process engineering, validation and Operational Excellence in a regulated environment.
• Strong knowledge of Shingo, Lean Six Sigma, standard work and continuous improvement.
• Demonstrated capability in SPC, process capability, MSA, DOE, hypothesis testing.
• Knowledge of ISO 13485, GMP, risk management, change control and compliant documentation.

Responsibilities

• Provide timely technical support and measurable process-performance improvement for critical manufacturing processes and equipment.
• Lead site-wide structured problem solving using DMAIC, 5 Why, Ishikawa and risk-based analysis.
• Balance hands-on technical support with strategic process-control and continuous-improvement priorities.
• Collaborate with Operations, Quality, Validation, Engineering, Supply Chain, Finance, Regulatory and site leadership.
• Prepare clear technical assessments, risk evaluations and validation support documentation.
• Coach engineers and cross-functional teams in statistical methods and Operational Excellence.
• Lead process characterisation, readiness for validation, and technology transfer with compliant documentation.

Skills

Process Engineering

Regulated manufacturing

Statistical methods

Project leadership

DMAIC method

Quality systems

GMP ISO13485

Change control

Education

Engineering degree

Bachelor's degree in Engineering

Tools

SPC software

DOE

MS Office

Statistical software

Job description

LGC Limited in Maryland, USA seeks a Principal Process Engineer to serve as the site technical lead for current-state process performance in regulated IVD quality-control manufacturing. The role drives BAU process engineering support, process capability, validation and technology transfer.

You will collaborate with Operations, Quality, Validation, Engineering, Supply Chain and Regulatory, providing technical leadership, coaching and data-driven problem solving.