Principal Process Engineer

• Employment Type: Full-time
• Work Arrangement: On-site
• Department: Engineering

About the Position

LGC Clinical Diagnostics is seeking a Principal Process Engineer to lead technical support and process improvement in regulated IVD manufacturing. This role is pivotal in ensuring the performance and efficiency of manufacturing processes, working closely with various departments to drive Operational Excellence.

Responsibilities

• 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.
• 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.
• Type of Work: Balance hands-on technical support and rapid issue resolution with strategic process-control, capability-building, and continuous-improvement priorities.
• Key Stakeholders: Partner cross-functionally with Operations, Quality, Validation, Engineering, Supply Chain, Finance, Regulatory, and site leadership.
• 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.
• 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.
• Subject Matter Expertise: Act as the 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.

Requirements

• 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 optimization, 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.

We Offer

• Competitive salary
• 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

About the Company

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.

Join us in this unique opportunity to be part of a company that is leading advancements in the industry!