Controls Engineer

Join us as a Controls Engineer!

Join Abeona Therapeutics as a Controls Engineer in our Engineering department and be a part of a mission-driven organization devoted to putting patients first. In this role, you will play a crucial part in ensuring that our cutting-edge health care solutions meet the highest quality standards and support the site in maintaining operations. Collaborate with talented individuals dedicated to transforming lives through innovative therapies.

Abeona Therapeutics Inc.: Who We Are

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

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.

Your day-to-day as a Controls Engineer

The Controls Engineer is responsible for the design, implementation, commissioning, maintenance, and continuous improvement of automation and control systems supporting GMP manufacturing operations. This role ensures compliance with FDA, cGMP, and company quality standards while optimizing process performance, reliability, and data integrity. The Controls Engineer will support PLC, HMI, SCADA, and industrial network infrastructure associated with manufacturing, utilities, and laboratory systems. To be successful as a Controls Engineer, one should be able to perform system evaluations, troubleshoot, and establish operational efficiency.

Work Location & Schedule

This role is fully on site at our Cleveland facilities. The general working hours for this role are Monday to Friday from 8:00 AM to 4:30 PM (with some late night or weekend work on occasion).

Does this sound like you?

You're a hands-on automation expert with an engineering degree and 3-5 years of experience in GMP or other regulated manufacturing, equally comfortable programming Rockwell Allen-Bradley PLCs, building HMI/SCADA applications, and reading electrical schematics and P&IDs. You thrive on troubleshooting, analyzing process trends, and turning insights into continuous improvements that keep critical equipment running. You take safety, quality, and compliance seriously, from 21 CFR Part 11 to GAMP 5 validation, and your clear, thorough documentation stands up to audits. As a strong communicator who juggles multiple projects and partners seamlessly with vendors and cross-functional teams, you're ready to bring your expertise to a mission that puts patients first.

Essential Responsibilities and Duties

• Design, program, troubleshoot, and maintain PLC-based control systems to minimize downtime.
• Develop and modify HMI and SCADA applications to support manufacturing operations.
• Support process equipment including humidifiers, chillers, HVAC, refrigerators, freezers, autoclaves, and incubators.
• Analyze process trends and identify opportunities for continuous improvement.
• Apply standard practices and techniques in solving problems related to facilities operation and automated support systems
• Investigate deviations and implement corrective and preventive actions (CAPA).
• Contribute data/findings for use in technical reports, documents, or oral/written presentations.
• Support CSV (Computer System Validation) activities in accordance with FDA regulations and GAMP 5 guidelines.
• Prepare and execute:
  • User Requirement Specifications (URS)
  • Functional Specifications (FS)
  • Design Specifications (DS)
  • Commissioning protocol and report
• Apply 21 CFR Part 11 requirements for electronic records and signatures.
• Manage change controls and engineering records.
• Ensure version control of automation software and configurations.
• Maintain control system documentation, network diagrams, and software backups.
• Support facility audits and regulatory inspections.
• Collaborate cross functionally with various teams as required.
• Coordinate with equipment vendors, integrators, contractors, and internal stakeholders and oversee their on-site activities.
• Perform minor repair work in one or more of the following areas: electrical, building utilities, and HVAC.
• Oversee preventative maintenance and calibration schedules of GMP manufacturing, laboratory, and utility equipment in accordance with the OEM recommendations and internal SOPs as Equipment Coordinator.
• Document and maintain records of Out Of Service tags, Non-Routine Maintenance, and work performed by external contracts.
• Respond to building management and environmental monitoring system alarms.
• Ahere to gowning requirements for Classified Areas of the facility (ISO 7 and 8 sterile gowning).
• Rotating weekend/after-hours availability for on-call alarm monitoring and support.
• Other duties as assigned.

Required Qualifications

The background, knowledge, and skills required to be successful in the role are:

• Bachelor's Degree or higher in Electrical Engineering, Controls/Computer Engineering, Mechanical Engineering with Automation focus, or related discipline.
• 3-5 years of work experience in GMP facility, mechanical, electrical, or other regulated manufacturing environments.
• Experience in pharmaceutical, biotechnology, medical device, or life sciences industries preferred.
• Experience with AutoCAD and MS Office.
• Ability to read Electrical schematics, P&IDs, and automated code.
• Ability to write SQL code.
• Must have experience with PLC Platforms (i.e. Rockwell Allen-Bradley ControlLogix) and HMI/SCADA (i.e. Factory Talk View and Niagara (HVAC)).
• Must be comfortable working within Industrial Networks (i.e. Ethernet/IP, Modbus TCP/IP/RS 485, Backnet/Lonworks, and ISO-14644).
• Knowledge of relevant regulations and Good Engineering Practices.
• Strong verbal and written communication skills.
• Project management skills, with ability to manage multiple projects simultaneously.
• Strong analytical and troubleshooting skills.
• Excellent technical writing and documentation abilities.
• Demonstrated commitment to safety, quality, and regulatory compliance.
• Ability to work effectively in cross-functional teams.

Compensation and Benefits

• The anticipated base salary range for this position is $110,000 to $120,000 (Actual compensation will depend on experience, qualifications, and work location)
• Annual discretionary bonus
• Equity opportunities
• Robust health coverage options
• FSA/HSA options
• Company-paid basic dental and vision plans
• Lifestyle spending account (wellness reimbursements)
• 401(k) retirement plan
• Up to 160 hours of paid time off accrual per calendar year (prorated based on date of hire)

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 sit for prolonged periods, some bending, stooping, and stretching. Hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required. A normal range of hearing and vision correctable to 20/20 is required. Occasional work in laboratory, cleanroom, or manufacturing environments may be required. Occasional lifting of up to 25 pounds is required. May require wearing appropriate personal protective equipment (PPE) when entering GMP or lab areas. Occasional walking, standing, or climbing stairs within office or facility settings. Must be able to travel between company sites or to vendor locations, if needed.

Important Notes for Candidates:

Visa Sponsorship Not Currently Available

• 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.
• This is a career-path role that is not suitable for someone whose work authorization is temporary and based on optional practical training (OPT).
• Current or future H-1B sponsorship is not available for this role.

Additional Notes to Applicants:

• Due to the volume of applications received, we are unable to respond to every applicant. Only candidates whose qualifications most closely match the requirements of the position and who successfully complete the initial stages of the selection process will be contacted.
• All applications will be reviewed in accordance with applicable federal, state, and local employment laws.

EEOC Disclaimer

We're committed to building a workplace where everyone feels welcome. We are an equal opportunity employer and do not discriminate based on race, color, religion, sex, gender identity or expression, sexual orientation, age, disability, veteran status, or any other protected status.

Connect with our team today!

If you're ready to take your career to the next level and join a team that values hard work and changing lives - complete our application today!