Abeona Therapeutics · 1 day ago
Senior Plant Engineer
Cleveland, OH
Full-time
Onsite
Mid, Senior Level
$115K/yr - $132K/yr
6+ years expAbeona Therapeutics is a commercial-stage biopharmaceutical company focused on developing cell and gene therapies for serious diseases. The Senior Plant Engineer will be responsible for the design, implementation, and maintenance of critical GMP plant systems, ensuring operational efficiency and compliance while supporting manufacturing and R&D initiatives.
BiotechnologyGeneticsHealth CareManufacturingMedical Device
No H1B
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
Qualification
Required
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
Preferred
Experience with Blue Mountain, Maintenance Management Software
Benefits
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)
Company
Abeona Therapeutics
Abeona Therapeutics develops gene therapy-based potential cures for Sanfilippo syndrome types A and B.
201-500 employees
Funding
Current Stage
Public CompanyTotal Funding
$429.7M2024-05-03Post Ipo Equity· $75M
2024-01-08Post Ipo Debt· $20M
2023-07-03Post Ipo Equity· $25M
Leadership Team
Vishwas Seshadri
President & CEO
Greg Gin
Vice President, Investor Relations and Corporate Communications
Recent News
2025-12-16
Company data provided by crunchbase