Principal Process Engineer

The Principal Process Engineer is the site technical lead for current-state process performance within regulated IVD quality control manufacturing. The role is accountable for business-as-usual process engineering support, process capability and control, recurring technical problem solving, yield and right-first-time improvement, Operational Excellence and day-to-day Shingo deployment. The role also provides process-engineering input to expansion, validation, new product introduction and technology transfer. The role works closely with Operations, Quality, Validation, Engineering, Supply Chain, Finance, Regulatory, site leadership and external equipment or technology partners. This is an individual contributor role with responsibility for technical leadership, coaching and influence rather than direct people management. To perform this job successfully, an individual must be able to capably perform each of the following essential duties: Business Impact: Provide timely technical support and measurable process-performance improvement for critical manufacturing processes, equipment and automation. Improve process capability, yield, throughput, right-first-time performance, quality and cost, and provide evidence of benefits delivered through business-as-usual initiatives. Innovation & Change: 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. Exercise independent technical judgement and escalate quality, compliance or business risks appropriately. Type of Work: Balance hands-on technical support and rapid issue resolution with strategic process-control, capability-building and continuous-improvement priorities. Support process readiness, ramp-up and sustainable project-to-business-as-usual handover. Key Stakeholders: Partner cross-functionally with Operations, Quality, Validation, Engineering, Supply Chain, Finance, Regulatory and site leadership. Provide process data, risk inputs and subject-matter support to expansion, capacity, CAPEX, layout, material-flow, equipment and automation projects. Communications: Prepare and communicate clear technical assessments, investigation outputs, risk evaluations, validation support documentation, process-performance reports and recommendations to technical and non-technical stakeholders. People Management: No direct people-management accountability. Coach engineers and cross-functional teams in process engineering, statistical methods, structured problem solving and Operational Excellence practices. Process Oversight: Lead process characterisation and readiness for validation, new product introduction and technology transfer. Support commissioning, IQ, OQ, PQ, deviation resolution and compliant documentation, with Quality and Validation retaining approval authority. Maintain process flows, value-stream maps, P&IDs and process-control documentation. Subject Matter Expertise: Act as site process subject-matter expert for critical process parameters, critical quality attributes, controls integration, process-control strategies, manufacturing equipment and automation. Continuous Improvement: Lead Operational Excellence delivery and sustainment through standard work, process confirmation, visual management, waste reduction, flow improvement and Shingo-aligned daily improvement systems. Data & Metrics: Deploy and coach statistical process control, process capability analysis, measurement systems analysis, design of experiments, hypothesis testing, trend analysis and statistical thinking to strengthen process control and decision making. Physical Demands: Work is primarily office-based with regular manufacturing-floor exposure. The role requires the ability to move through production areas, use standard computer equipment and wear required personal protective equipment. Policy & Standards Compliance: Comply with applicable quality-system, GMP, ISO 13485, safety, environmental, change-control, risk-management, data-integrity and documentation requirements. Other Duties As Assigned: Perform other duties as required or assigned by management to meet business needs Knowledge, Experience, Skills, and Certifications Essential Knowledge and Qualifications: Degree in Engineering, Science, Manufacturing, Chemical, Mechanical, Biomedical, Process Engineering or a 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…