Manager, Manufacturing & Processing Engineering (Facilities & Validation)

<div class="content-intro"><p>Axogen is committed to building and maintaining a strong and gratifying company culture that fosters professional growth. Our hands-on and personal approach makes transitioning to a new job a seamless and enjoyable process. Most benefits are effective on day one! </p> <p>Axogen is an equal opportunity employer and does not discriminate against applicants on the basis of race, color, creed, religion, ancestry, age, sex, marital status, national origin, disability or veteran status. </p> <p> Why you’ll love working at Axogen: </p> <ul> <li>Friendly, open, and fun team culture that values unique perspectives </li> <li>Company-wide dedication to profoundly impacting patients’ lives </li> <li>Comprehensive, high-quality benefits package effective on date of hire </li> <li>Educational assistance available for all employees </li> <li>Matching 401(k) retirement plan </li> <li>Paid holidays, including floating holidays, to be used at your discretion </li> <li>Employee Stock Purchase Plan </li> <li>Referral incentive program </li> </ul> <p><strong>Axogen Mission and Business Purpose</strong></p> <p>Our business purpose is to restore health and improve quality of life by making restoration of peripheral nerve function an expected standard of care. We aim to lead the markets we serve by always requiring the solutions we offer patients and caregivers provide an improved benefit-to-risk profile as compared to existing standards of care. To ensure we deliver improved benefit-to-risk solutions, we will guide and expect the market and design requirement specifications underlying our engineering, business development, and clinical research activities, objectively target advancements in standards of care.</p></div><p><strong>Job Summary of the Manager, Manufacturing & Processing Engineering </strong></p> <p>The Manager, Manufacturing & Processing Engineering will provide focused project leadership and technical support to Operations with an emphasis on production support, decision-making, project management, equipment qualification, standard operating procedures, standard costing, capacity analysis, yield improvements, cost reduction, planning, validations and metrology. The Manager serves as the functional leader for a designated operations area, which may include <strong>Manufacturing & Processing Engineering, Packaging & Labeling, Facilities & Validation, Cleaning & Sterilization</strong>, or other operational support functions, ensuring alignment with business objectives, regulatory requirements, and continuous improvement initiatives.</p> <p><strong>Requirements of the Manager, Manufacturing & Processing Engineering </strong></p> <ul> <li>Bachelor’s Degree in Engineering or related discipline and a minimum of 5 years of related experience OR a Master’s Degree in Engineering or related discipline and a minimum of 3 years of related experience.</li> <li>Preferred experience in biotech, biomedical, or pharmaceutical manufacturing.</li> <li>Experience in cGMP with alignment of AATB and FDA standards is preferred.</li> <li>Demonstrated presentation and communication skills at all levels and deliver highly technical information with clarity. This includes technical writing (e.g., protocols, reports, procedures, specifications, portions of regulatory submission documents) as well as preparing and making presentations</li> <li>Demonstrated hands-on technical skills </li> <li>Preferred experience with Lean Six Sigm