Senior Plant Engineer

Company: Abeona Therapeutics Inc.
Location: Cleveland
Posted on: February 13, 2026

Job Description:

Job Description Job Description About Abeona 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. Company Description 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. Position Overview 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) Essential Duties and Responsibilities 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. Qualifications 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 manufacturing environment. Proven experience with plant utilities, equipment commissioning/qualification, and process optimization. Strong knowledge of cGMPs and industry best practices. Strong data analysis and critical thinking skills to drive continuous improvement initiatives. Excellent troubleshooting and problem-solving skills. Proven ability to manage multiple projects and priorities. Strong communication and interpersonal skills. Experience with Quality Events, change controls, CAPA, investigations, deviation management, and audit support. Proficiency in creating and updating technical documentation and design specifications. Familiarity with automation and control systems (Rockwell Automation preferred). Ability to lead cross-functional teams. Basic familiarity in CAD software and other engineering tools. Experience with Blue Mountain, Maintenance Management Software (preferred). Physical Demands The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to experience prolonged sitting, some bending, stooping and stretching. Hand-eye coordination and manual dexterity sufficient to operate office equipment is required. A normal range of hearing and vision correctable to 20/20 is required. Occasional lifting of up to 50 pounds is required. This position may require occasional evening or weekend work to address urgent issues or meet project deadlines. The role involves working in both office and plant environments, with exposure to manufacturing equipment and processes. Benefits Our values apply to how we view caring for each other as well. While the patient comes first, our employees are vital to making that happen, and so we strive to offer a competitive benefits package that includes: Medical insurance coverage (multiple options to meet our employees' and their families' needs) Dental and vision coverage 401k match plan Lifestyle spending account PTO: 160 hours of paid time off per calendar year (Prorated based on date of hire; can carry 40 hours over to the next year) Compensation (annual): $115,000 - $132,000 (this range includes the base annual salary, plus the anticipated annual bonus) Visa Sponsorship Not Currently Available IMPORTANT: Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

Keywords: Abeona Therapeutics Inc., Warren , Senior Plant Engineer, Engineering , Cleveland, Michigan