Principal Process Engineer

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, Sera Care 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.

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 elevate 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,…