Life. Unlimited. At SmithNephew we design and manufacture technology that takes the limits off living. Are you ready to lead critical validation projects that ensure our advanced medical technologies meet the highest standards? This is your chance to make a real impact on patient outcomes while driving innovation and compliance in a global organization. What will you be doing? You’ll take ownership of validation activities for new processes, technologies, and modifications to existing systems. From developing site-wide validation master plans to creating data-driven protocols, you’ll ensure every piece of equipment and process meets regulatory and quality requirements before it reaches commercial manufacturing. Validation Leadership (80%) Developing and owning the Melton site VMP pre handover. Developing and owning the Melton site CCA programme pre handover. Creating specific, data driven validation plans for all equipment and manufacturing processes, for both new and existing equipment. Use statistical methods and experience to value engineer protocols to minimise technical effort whilst maintaining quality of output. Leading SN Operations through complex statistical benchmarking in order to determine appropriate protocols for verification activities. Preparing all the necessary compliance documentation for the Technical and Engineering project teams. Continuous Improvement (20%) Coaching and leading others. Provide guidance to senior engineers in development, improvement, and maintenance of manufacturing documentation. Approver of manufacturing documentation. Strong problem solving and root cause analysis capability. Analyses of highly complex technical problems in the manufacture or purchase of raw material through to finished goods. Able to perform Root Cause Analysis, Value Stream Mapping, Design Transfer/Risk Management deliverables, basic understanding of Value Analysis Value Engineering, Measurement System Analysis, Design for Manufacture analysis, Lean manufacturing principles and 6 Sigma. What will you need to be successful? Success in this role means combining technical expertise with leadership and problem-solving skills. You’ll need to: Hold a degree in a STEM discipline and bring broad experience in process validation within a manufacturing environment Broad experience of process validation in a manufacturing Demonstrate effective project management and a proven knowledge and understanding of documentation/quality systems within Smith & Nephew Advanced Wound Management. Lean Sigma black belt (preferred) Broad understanding of process equipment, risk analysis, criticality matrices. You. Unlimited. We believe in creating the greatest good for society. Our strongest investments are in our people and the patients we serve. Inclusion and Belonging: Committed to welcoming, celebrating and thriving on inclusion and belonging. Learn more about our Employee Inclusion Groups on our website www.smith-nephew.com Your Future: Generous annual bonus and pension schemes, Save As You Earn share options Work/Life Balance: Flexible vacation and time off, paid holidays and paid volunteering hours so we can give back to our communities Your Wellbeing: Private health and dental plans, healthcare cash plans, income protection, life assurance and much more Flexibility: Hybrid working model (for most professional roles) Training: Hands-on, team-customised, mentorship Extra Perks: Discounts on gyms and fitness clubs, salary sacrifice bicycle and car schemes and many other employee discounts SmithNephew is committed to societal good through investments in people and patients, emphasizing inclusion, generous financial benefits, work-life balance, wellbeing programs, flexible hybrid work, tailored training, and various employee perks such as discounts and health plans. LI-KK1 Stay connected by joining our Talent Community. We're more than just a company - we're a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day. Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at SN. Explore our website and learn more about our mission, our team, and the opportunities we offer. Stay connected by joining our Talent Community. We're more than just a company - we're a community! Follow us on LinkedIn to see how we support and empower our employees and patients every day. Check us out on Glassdoor for a glimpse behind the scenes and a sneak peek into You. Unlimited., life, culture, and benefits at SN. Explore our website and learn more about our mission, our team, and the opportunities we offer.