Senior Staff Quality Validation Engineer

Work Flexibility: Hybrid<p></p><p></p><p><b>Position requirements</b></p><p>Participating in the definition of the Stryker validation strategy to be outlined in Corporate procedures and based on regulatory requirements.</p><p>Responsible for local validation teams in terms of technical expertise and definition of best practices.</p><p>Supporting validation activities by providing guidance and expertise to authors of validation documentation and executors of validation protocols at several sites.</p><p>Reviewing and approving of validation documentation to ensure compliance with regulations and validation best practices.</p><p></p><p></p><p>Will work within the QA group, responsible for validation related activities, including, but not limited to the following:</p><ul><li>Having knowledge of and ability to provide Interpretation and Guidance on Regulations, Corporate, Divisional and Site Local procedures as they relate to validation activities.</li><li>Participating within Corporate Validation Team to develop and revise Validation Procedures and Templates to ensure that Current Regulatory Compliance and Company Objectives are maintained.</li><li>Being Subject Matter Expert in more than 1 validation specialty for development of Corporate Procedures and Work Instructions.</li><li>Participating on both Corporate and Local Validation Teams to discuss / give feedback and approve revisions to Validation Procedures.</li><li>Representing validation at both internal and external audits. </li><li>Ensuring that Validation Practitioners receive training/coaching to allow them to effectively support and/or perform validations for current and anticipated projects.</li><li>Ensuring that appropriate Systems are in place to evaluate changes to Validated/Qualified Systems to ensure their continued validated/qualified state.</li><li>Ensuring that appropriate Site Validation Listing is established and controlled as per Current Regulatory and Company Requirements.</li><li>Reviewing and approving of <span>Validation/Qualification</span> Documentation.</li><li>Working with Validation <span>Consultants/Contractors</span> as required ensuring that Validations are completed as per corporate and divisional procedures.</li><li>Mentoring for Graduate Validation Engineers</li><li>Establish Validation standards in terms of Industry Best Practices and drive this level across the organization</li><li>Having multi-site responsibility for at least 1 validation specialty.</li></ul><h2>Qualification Knowledge Skills</h2><ul><li>Bachelor of Science, Engineering or related subject and 6 plus years of experience in validation.</li></ul><p></p><ul><li>Excellent communication skills and attention to detail.</li><li>Have a good understanding of engineering and machine tool fundamentals.</li><li>Advanced level of PC skills.</li><li>Must be proficient with Microsoft Word, Microsoft Excel and PowerPoint packages.</li><li>Self-starter with demonstrated efficient work methods, analytical &amp; problem solving skills and ability to handle multiple tasks in a fast paced environment.</li><li>Must be willing to work as part of a multi-site team, be able to travel as part of the job</li><li>Expert Knowledge of Computer System Validation including GAMP 5 and 21 CFR part 11 requirements desirable.</li><li>Working knowledge/experience of Risk Based Techniques i.e. FMEAs, FTAs etc.</li><li>Have a good understanding of statistical techniques, in particular statistical sampling plans, Process Capability, Gauge R&amp;Rs, MSA</li><li>Lean Six Sigma training a distinct advantage.</li><li>Excellent knowledge of all validation elements (all validation documents and specialties)</li><li>Expert Knowledge in at least 1 validation specialty.</li><li>Strong knowledge of Quality Concepts (e.g. CAPA, Audits, Statistics).</li><li>Thorough knowledge and understanding of International Medical Device Regulations.</li><li>Experience in working in a compliance risk situation.</li><li>Experience in interacting with regulatory agencies (FDA, TÜV, etc.).</li><li>Highly developed problem solving and strong analytical skills.</li><li>Mentor or trainer for validation subjects.</li><li>Qualification in statistical techniques.</li><li>Project Management training or skills.</li></ul><p></p><p>#IJ</p><p></p><p></p>Travel Percentage: 20%<p></p><p></p><p></p><p></p><p></p><p></p><p></p><p></p>