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Validation Engineering Manager
<p>Position Summary</p><p><br></p><p>We are seeking a Validation Engineering Manager to lead a team of validation engineers supporting manufacturing processes, equipment, and systems in a regulated CBR environment — including blood bank, gene therapy, biologics, and vaccine operations. This individual will set validation strategy, ensure compliance with FDA and cGMP standards, and partner cross-functionally with Quality, Manufacturing, and R&D. </p><p><br></p><p>Key Responsibilities</p><p><br></p><ul><li>Manage, mentor, and develop a team of validation engineers</li><li>Set team priorities, allocate resources, and ensure projects are completed on schedule</li><li>Define and drive validation strategy for processes, equipment, utilities, and systems</li><li>Oversee authoring and execution of validation documentation (URS, IQ, OQ, PQ, Validation Summary Reports)</li><li>Maintain the Master Validation Plan and lead change control activities</li><li>Review and approve validation protocols and reports; present findings to leadership</li><li>Ensure compliance with FDA regulations and cGMP; lead regulatory inspections and audits</li></ul><p><br></p><p>Qualifications</p><p><br></p><ul><li>Bachelor's degree in Engineering or related technical field</li><li>10+ years of validation experience in a regulated industry; 3+ years in a management or team lead role</li><li>Direct experience in one or more CBR disciplines: blood bank, gene therapy, biologics, or vaccine</li><li>Strong experience with process validation and equipment qualification</li><li>Knowledge of FDA regulations and cGMP</li></ul><p><br></p><p><strong>Preferred</strong></p><p><br></p><ul><li>Experience across multiple CBR disciplines</li><li>Sterilization validation</li><li>Microbiological / microvalidation experience</li></ul><p></p>
