Lead Process Engineer, Operational Excellence
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Benefits offered by this job
Job summary
LGC Limited, a leading life sciences company, seeks a Principal Process Engineer to act as the site technical lead for regulated IVD quality-control manufacturing. You will drive process capability, QA-compliant validation readiness, and cross-functional collaboration to deliver reliable product quality.
The role emphasizes hands-on technical support, problem solving, and coaching in statistical methods and Lean practices to support capacity expansion, tech transfer and continuous improvement
Qualifications
- Degree in Engineering or related technical discipline.
- Typically 10+ years of experience in regulated medical device, diagnostics, IVD, pharmaceutical, life sciences or similarly controlled manufacturing.
- Proven leadership in business-as-usual process engineering, process optimisation, capability improvement, validation and Operational Excellence within a regulated environment.
- Strong practical knowledge of Shingo principles, Lean Six Sigma, standard work, value-stream improvement and sustainable daily management.
- Demonstrated capability in SPC, process capability, MSA, DOE, hypothesis testing and statistical problem solving.
- Strong knowledge of process characterisation, commissioning, IQ, OQ, PQ, ISO 13485, GMP, risk management, change control and compliant documentation.
Responsibilities
- Provide timely technical support and measurable process-performance improvement for critical manufacturing processes, equipment and automation.
- Lead site-wide structured problem solving for recurring deviations and complex performance issues using DMAIC, A3, 5 Why, Ishikawa, FMEA and risk-based root cause analysis.
- Balance hands-on technical support and rapid issue resolution with strategic process-control, capability-building and continuous-improvement priorities.
- Partner cross-functionally with Operations, Quality, Validation, Engineering, Supply Chain, Finance, Regulatory and site leadership.
- Prepare and communicate clear technical assessments, investigation outputs, risk evaluations, validation support documentation, process-performance reports and recommendations.
Skills
Education
Tools
Job description
LGC Limited, a leading life sciences company, seeks a Principal Process Engineer to act as the site technical lead for regulated IVD quality-control manufacturing. You will drive process capability, QA-compliant validation readiness, and cross-functional collaboration to deliver reliable product quality.
The role emphasizes hands-on technical support, problem solving, and coaching in statistical methods and Lean practices to support capacity expansion, tech transfer and continuous improvement
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