Validation Lead (2 years fixed term contract) in Woodbridge

At Smith+Nephew 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 S+N 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.

• 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.

Smith+Nephew 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.