At Johnson & Johnson,?we believe health is everything. Our strength in healthcare innovation empowers us to build a?world where complex diseases are prevented, treated, and cured,?where treatments are smarter and less invasive, and?solutions are personal.?Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.?Learn more at https://www.jnj.com Job Function: Supply Chain Engineering Job Sub Function: Process Engineering Job Category: Scientific/Technology All Job Posting Locations: West Yorkshire, England, United Kingdom Job Description: About Orthopaedics Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Orthopaedics? Ready to join a team that's reimagining how we heal? Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery. Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes. Position Overview The Process Engineer is responsible for owning and improving assigned manufacturing value streams to ensure safe, compliant and cost-effective production of medical devices. This role provides hands-on technical support, leads process development and continuous improvement initiatives, and collaborates across Operations, Maintenance, Quality, R&D and suppliers to maintain process stability and supply continuity. The incumbent will execute validation activities including Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) for equipment, processes and systems, drive timely closure of quality actions (Audit Actions, NCs, CAPAs), and apply structured problem-solving tools to implement robust corrective and preventive measures. Key Responsibilities - Provide hands-on engineering support to achieve key business metrics (HSE, Quality, Supply, Cost) for assigned value stream processes. - Lead process development and improvement activities to create stable, capable and validated manufacturing processes. - Plan, prepare and execute validation activities including Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) for equipment, processes and systems, ensuring documentation is complete and compliant with the Quality Management System. - Manage quality actions and corrective activities (Audit Actions, NCRs, CAPAs) to timely closure and sustained resolution. - Support NPI activities and collaborate with cross-functional teams and external vendors on tooling, fixtures, gauges and special equipment. - Work closely with in-house maintenance and calibration teams to define requirements, support troubleshooting and improve equipment performance. - Apply structured problem-solving and root cause analysis tools (8D, FMEA, Six Sigma, etc.) to investigate issues and implement robust corrective and preventive actions. - Deliver cost reduction initiatives such as scrap reduction, rework minimisation and consumables optimisation. - Participate in day-to-day operations (pulse walks, production support) and ensure timely closure of operational actions. - Prepare and maintain technical documentation and manufacturing specifications for process steps and ensure changes follow change control and validation requirements. - Ensure all engineering activities comply with regulatory, quality and safety requirements. Required Qualifications & Experience - Bachelor's degree in Engineering (or equivalent) or significant relevant manufacturing engineering experience - Minimum 2 years' experience in similar engineering role - Practical experience in a regulated manufacturing environment (medical device experience preferred) - Demonstrated experience executing validation activities including Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) for equipment, processes and systems - Proven experience managing Audit Actions, NCs and CAPAs within a Quality Management System - Problem solving experience using structured tools (e.g., 8D, root cause analysis) - Strong technical documentation skills (specifications, validation protocols, change control) Preferred Qualifications & Experience - Proficiency in CAD/CAM and working with tooling, fixtures and gauges - Knowledge of regulatory requirements applicable to medical device manufacturing - Training or certification in Six Sigma, Lean, or equivalent continuous improvement methodologies - Experience with FEA, DFMA, FMEA or other design/process risk assessment tools - Proven track record of delivering NPI support and equipment/process introductions - Project management experience, including planning, coordination and supplier management - Familiarity with calibration, maintenance practices and working with in-house maintenance teams Key Competencies - Strong analytical and data driven decision making skills - Expertise in validation strategy and execution (IQ/OQ/PQ) - Structured problem solver with attention to root cause and long-term corrective actions - Effective cross functional collaborator and influencer (Operations, Quality, R&D, Suppliers) - Excellent written and verbal communication skills for technical documentation and stakeholder updates - Project organisation and prioritisation with ability to drive actions to timely closure - Continuous improvement mindset with focus on cost, quality and supply stability - Commitment to Health, Safety and Environmental (HSE) practices and regulatory compliance \LI-Fully Onsite Required Skills: Continuous Process Improvement, Process Validation, Quality Support Preferred Skills: Analytical Reasoning, Corrective and Preventive Action (CAPA), Emerging Technologies, Execution Focus, Gemba Kaizen, Issue Escalation, Lean Supply Chain Management, Process Control, Process Engineering, Process Oriented, Product Improvements, Project Engineering, Safety-Oriented, Science, Technology, Engineering, and Math (STEM) Application, Situational Awareness, Technical Research, Technologically Savvy