<p>At Vericel Corporation, we are pioneers in advanced cell therapies for sports medicine and severe burn care, transforming patient lives through cutting-edge regenerative medicine. Our commitment to innovation, patient-centered focus, and scientific excellence drives us to develop groundbreaking treatments including MACI (knee cartilage repair), Epicel and Nexobrid (burn care).</p> <p>Position Summary:</p> <p>The Engineering Lead is primarily responsible for the detailed design, startup, troubleshooting, commissioning, optimization and lifecycle support of manufacturing equipment, facilities, and utility systems. Additional responsibilities include supporting & leading capital projects, lean initiatives, cross functional teams and vendor management.</p> <p>Schedule:</p> <p>As a company that thrives on teamwork and collaboration, this role will be required to work five days per week on-site.</p> <p>Position Scope:</p> <ul> <li> <p>Staff Management:</p> </li><li> <p>Assist in selection, training and development of junior engineering staff to effectively carry out department functions and provide for the continuity of specialized skills.</p> </li><li> <p>Provide leadership, guidance, and direction to staff consistent with cGMP and company corporate quality governance.</p> </li><li> <p>Take the lead role in Engineering projects, by prioritizing work, developing work plans, assigning tasks to other engineers, and supervising cross-functional teams.</p> </li><li> <p>Ensure staff has appropriate knowledge of department processes and procedures.</p> </li><li> <p>Budget:</p> </li><li> <p>Provide input into the department budget.</p> </li><li> <p>Department Management:</p> </li><li> <p>Establish and report applicable department or organizational metrics.</p> </li><li> <p>Accountable for project completions and achievement of compliance goals.</p> </li><li> <p>Represent the Engineering department in project team meetings.</p> </li><li> <p>Serve as an Engineering department SME where required, including audits, change controls, and deviation investigations.</p> </li><li> <p>Manage and/or Interact with project teams and cross-functional groups</p> </li><li> <p>Additional Responsibilities:</p> </li><li> <p>Serve as the liaison between Engineering and other functional groups, including Facilities, Validation, Quality and Manufacturing.</p> </li><li> <p>Lead a group of engineers focused on engineering operations.</p> </li><li> <p>Develop work plans and provide guidance and direction to junior engineers.</p> </li><li> <p>Lead engineering efforts from preliminary/detailed design, commissioning and startup of projects.</p> </li><li> <p>Provide expertise in process equipment design, specification development and installation of such equipment and systems.</p> </li><li> <p>Author, review, approve and manage change controls and equipment deviations pertaining to the Engineering department in Quality System.</p> </li><li> <p>Act as Quality System subject matter expert for Engineering department.</p> </li><li> <p>Support the Facilities team in helping to troubleshoot utility and equipment problems, including outside normal working hours if necessary.</p> </li><li> <p>Other duties as assigned.</p> </li></ul> <p>Qualifications:</p> <ul> <li>Bachelor's degree or equivalent in biomedical, chemical, or mechanical engineering or technical science and 3 or more years of relevant experience or Master's degree and 1 or more years of relevant experience. </li><li>Excellent communication and technical writing skills. </li><li>Experience in working in a cGMP environment. </li><li>Ability to work in classified and controlled areas such as clean room environment wearing special garments. Additionally, personal protective equipment must be worn due to safety requirements. </li><li>Ability to work with tools and lift up to 50 lbs. </li><li>Ability to work after hours, including weekends. </li></ul> <p>Preferred Qualifications:</p> <ul> <li>Experience at supervising multi-disciplined technical staff and experience in supporting pharmaceutical manufacturing operations. </li><li>Possess strong leadership and communication skills, work well in a team environment, and be able to react to changing business needs. </li><li>Experience with Trackwise. </li><li>Experience with installing and maintaining cleanroom HVAC systems. </li></ul> <p>Why Vericel?</p> <ul> <li>Cutting-Edge Science: Work with a leading regenerative medicine product that is transforming patient care. </li><li>Career Growth: Be a part of a growing organization with opportunities to expand your impact. </li><li>Collaborative Culture: Work alongside a team of dedicated professionals who are passionate about improving lives. </li></ul> <p>EEO Statement</p> <p>All applicants will receive consideration for employment without regard to their race, color, religion, sex, national origin, sexual orientation, gender identity, or protected veteran status and will receive consideration for employment and will not be discriminated against on the basis of disability. Vericel Corporation is an Equal Opportunity/Affirmative Action Employer.</p> <p>Vericel Corporation is VEVRAA federal contractor and desires priority referrals of protected veterans for job openings at all locations within the state.</p>