Principal Process Engineer

Job description

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 knowledge of process characterisation, commissioning, IQ, OQ, PQ, ISO 13485, GMP, risk management, change control and compliant documentation. Desired Knowledge and Qualifications: Lean Six Sigma Green Belt or Black Belt, Shingo-aligned improvement experience, or an equivalent Operational Excellence qualification. Experience supporting capacity expansion, CAPEX, equipment introduction, automation, new product introduction or technology transfer. Experience coaching technical teams in structured problem solving and statistical methods. Working knowledge of data-analysis, visualisation, manufacturing information or statistical software. Experience in IVD quality-control or comparable biological or chemical manufacturing processes. Behavioural and Interpersonal Competencies: Resonates and operates in line with LGC’s core value behaviours: Passion, Curiosity, Integrity, Brilliance and Respect. Acts with ownership, accountability, urgency and discipline for process performance and improvement commitments. Influences through data, sound technical judgement, systems thinking and clear cross-functional communication. Coaches others and builds sustainable problem-solving, statistical and Operational Excellence capability. Balances practical execution with compliance, risk management and long-term process control. Demonstrates autonomy, recognises when stakeholder engagement is required and escalates appropriately. Adapts priorities effectively while managing multiple technical demands in a dynamic manufacturing environment. Drives results while maintaining quality, safety, budget and schedule expectations. Builds cooperation and commitment across cross-functional teams. Maintains a strong internal-customer focus and develops effective working relationships. Approaches complex process problems with curiosity, persistence and disciplined analysis. Demonstrates professional judgement, tact, approachability and discretion when handling confidential or proprietary information. Work Conditions AND Environment Travel & Time Expectations: Travel outside the local area, including occasional overnight or overseas travel, may be required. Normal working hours are Monday to Friday during standard site operating hours, with flexibility to meet business needs. Work Setting: Primarily an office setting with regular exposure to manufacturing and laboratory areas. Distinctive Safety Conditions: The work environment is generally moderate in noise level. Potential exposure to hazardous or caustic materials may occur in controlled areas, subject to established procedures and training. Required Personal Protective Equipment (PPE): Comply with the company PPE policy when entering laboratory, manufacturing or other designated areas. LGC is a top life science tools company, offering important solutions in growing markets. Our values PASSION CURIOSITY INTEGRITY BRILLIANCE RESPECT Benefits 25 days holidays Life assurance & health allowance Discounts with local and national retailers Free 24/7 Employee Assistance Programme Recognition schemes and monetary awards Great long-term career opportunities At LGC, we foster a culture of inclusion and collaboration. We believe that diverse perspectives lead to better outcomes and encourage applicants from all backgrounds to apply. We are an equal opportunity employer and offer reasonable accommodations to individuals with disabilities. If you require any adjustments throughout the recruitment process, please let us know. Join us in this unique opportunity to be part of a company that is leading advancements in the industry! #lgcij LGC Clinical Diagnostics develops and manufactures a range of diagnostic quality solutions and component materials for the life sciences industry. We partner with IVD assay developers, and pharmaceutical, CRO and academic institutions in commercialisation activities across the entire diagnostic pipeline. Laboratorians and diagnostic professionals rely on LGC’s products to support accurate and reliable diagnostic results. Our operating entities include Maine Standards Company, SeraCare Life Sciences, and Technopath Clinical Diagnostics, which are in vitro diagnostics (IVD) manufacturers of quality measurement tools (calibrators, controls, linearity, EQA/PT, biological materials), the Native Antigen Company, which is a manufacturer and supplier of viral antigens and LGC Proficiency Testing a global leader in PT schemes. We operate FDA-registered and ISO 13485-accredited facilities in Maine (USA), Massachusetts (USA), Maryland (USA), Tipperary (Ireland), ISO 9001-accredited facility in Oxford, UK, and Traverse City, Michigan US. Our exceptional team, scientific skills, operational efficiency, and high-quality systems are primed daily to assist various advanced technologies, benefiting patient outcomes.