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.
Job DescriptionThe 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
QualificationsKnowledge, 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
Skills Required
- Degree in Engineering, Science, Manufacturing, Chemical, Mechanical, Biomedical, Process Engineering, or a related technical discipline.
- Typically 10 or more years of experience in regulated medical device, diagnostics, IVD, pharmaceutical, life sciences, or similarly controlled manufacturing.
- Leadership experience in 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 statistical process control, process capability, measurement systems analysis, design of experiments, hypothesis testing, and statistical problem solving.
- Strong knowledge of process characterization, commissioning, IQ, OQ, PQ, ISO 13485, GMP, risk management, change control, and compliant documentation.
- Lean Six Sigma Green Belt or Black Belt, Shingo-aligned improvement experience, or 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, visualization, manufacturing information, or statistical software.
- Experience in IVD quality-control or comparable biological or chemical manufacturing processes.
LGC Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about LGC and has not been reviewed or approved by LGC.
-
Healthcare Strength — Health, dental, and vision coverage with FSA/HSA options are consistently part of the package, and private medical is cited where applicable in the UK. Coverage is often characterized as solid alongside other core benefits.
-
Retirement Support — Retirement offerings include a 401(k) with employer contribution in the U.S. and pension schemes in the UK, complemented by life and disability insurance. These elements are highlighted as part of a standard-to-competitive core package.
-
Leave & Time Off Breadth — Paid time off, holidays, sick leave, and family leave are broadly available, with some sites offering a year‑end shutdown. Flexibility and local leave programs contribute to a generally well-rounded time‑off offering.
LGC Insights
What We Do
LGC is a leading, global life science tools company, providing mission-critical components and solutions into high-growth application areas across the human healthcare and applied market segments. Its high quality product portfolio is comprised of mission-critical tools for genomic analysis and for quality assurance applications, which are typically embedded and recurring within our customers’ products and workflows and are valued for their performance, quality and range. LGC’s tools play a key role in customer workflows from discovery applications through to commercial manufacture and enable its customers to: bring new diagnostics and therapies to market; progress research and development; optimise food production; and continuously monitor and enhance the quality of food, the environment and consumer products. LGC’s 175+ years of scientific heritage, combined with a track record of innovation and value-enhancing acquisitions, has enabled the company to build its product portfolio and expertise, and develop deep relationships with customers, industry partners and the global scientific community. LGC’s core purpose of Science for a safer world and its core values of passion, curiosity, integrity, brilliance and respect, drive its culture. As of 30 June 2021, it employs 4,350 employees, of which over 1,175 employees hold PhD and/or master’s degrees. Its products and services are delivered by highly qualified and experienced teams, operating from a global network of accredited sites that showcase its scientific and manufacturing capabilities.
