Senior Plant Engineer

Our Values:
Patient First | Innovation | Integrity | Determination | Trust

Join us in making cure the new standard of care. At Abeona Therapeutics, we exist for our patients and their caregivers; their needs guide our decision-making. We challenge ourselves to think differently, move quickly, and deliver solutions. We hold ourselves to the highest ethical and quality standards. We persevere with resilience and focus to achieve our mission. We build trust through humility, mutual appreciation, openness, and respect.

Abeona Therapeutics Inc. is a commercial-stage biopharmaceutical company focused on developing cell and gene therapies for serious diseases. Notably, Abeona's ZEVASKYN™ (prademagene zamikeracel) is the first autologous cell-based gene therapy treating wounds in adults and pediatric patients with recessive dystrophic epidermolysis bullosa (RDEB). The company's cGMP manufacturing facility in Cleveland, Ohio, is dedicated to producing ZEVASKYN™. Abeona's portfolio includes adeno-associated virus (AAV)-based gene therapies for ophthalmic diseases with unmet medical needs, and their novel AAV capsids aim to improve treatment outcomes for various debilitating conditions.

This mid-career role, the Senior Plant Engineer, requires a highly skilled and experienced individual with a strong background in cGMP (current Good Manufacturing Practice) environments. This position is pivotal in the design, implementation, and maintenance of critical GMP plant systems within a biopharmaceutical manufacturing setting. Key responsibilities include ensuring operational efficiency, reliability, and compliance; supporting calibration, preventative maintenance; both manufacturing and R&D initiatives;

and completing commissioning and decommissioning activities. The role also involves evaluating and improving production and quality control processes while providing technical expertise and driving continuous improvement across various projects.

Standard

Work Hours:

Monday to Friday with start time between 8:00 and 9:00. (Availability to be on call or to work overtime outside of regular business hours (potential nights and weekends) as needed is required to be successful in this role)

• Utilize knowledge of GMP regulations and pharmaceutical/biopharmaceutical manufacturing processes to support Abeona processes.
• Execute equipment commissioning/decommissioning and maintaining equipment calibration and preventive maintenance with reasonable independence.
• Creation and maintenance of documentation to support equipment procurement (i.e. user requirement specification) and commissioning protocols.
• Troubleshoot equipment and control system failures to minimize downtime and ensure consistent production.
• Develop and support spare parts and preventative maintenance programs.
• In collaboration with engineers and technicians, establish calibration ranges and critical process parameters.
• Analyze and enhance manufacturing processes to boost efficiency, reduce costs, improve product quality, and minimize variability.
• Manage engineering projects from conception to completion, including budgeting, equipment procurement, scheduling, and execution.
• Manage vendors and contractor communications, supervise when on site, partner with them for technical reports and other services.
• Provide oversight of engineering solutions to enhance plant performance and compliance.
• Support shutdown activities and start-up operations.
• Strict adherence to safety protocols.
• Create and update technical documentation including URS, FDS, Process Flow Diagrams, P&IDs, and isometric drawings.
• Maintain detailed records of execution.
• Collaborate with production, quality assurance, quality control, R&D, and Facility teams.
• Provide Technical support for troubleshooting and process optimization across departments.
• Mentor and train junior engineers.
• Daily communication with stakeholders at all levels.

• Bachelor's degree in Engineering (Mechanical, Electrical, Chemical, Biomedical, or another similar field).
• 6 to 10 years of experience in a cGMP-regulated biopharmaceutical or pharmaceutical…