Computer Systems Validation Engineer

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

As a Computer System Validation (CSV) Engineer in a biotechnology environment, you will play a critical role in ensuring that computerized systems used in GxP-regulated activities (e.g., clinical, laboratory, manufacturing, quality) are validated and maintained in compliance with FDA, EMA, and other global regulatory standards. This role involves close collaboration with cross-functional teams to implement, validate, and sustain systems that support key biotech processes from R&D through commercial production.

Schedule: This position is scheduled Monday to Friday from 9:00 AM to 5:00 PM. This position is onsite but allows up to 1 day of remote work per week (depending on department priorities)

Essential Duties and Responsibilities

• Develop and execute validation deliverables for new and existing GxP systems in alignment with regulatory guidelines (21 CFR Part 11, EU Annex 11, GAMP 5).
• Partner with system owners, QA, IT, and vendors to define User Requirements Specifications (URS), and ensure traceability through Functional and Design Specifications, Test Plans, and Summary Reports.
• Lead CSV efforts for systems supporting biotech processes such as:
• Laboratory systems (e.g., LIMS, ELN)
• Clinical trial management systems (e.g., CTMS, EDC)
• Quality systems (e.g., QMS, Document Management Systems)
• Manufacturing systems (e.g., MES, SCADA)
• Conduct risk assessments and impact analyses to determine appropriate validation strategies.
• Ensure robust documentation practices that meet internal SOPs and inspection-readiness standards.
• Support change control processes, periodic reviews, revalidation efforts, and data integrity compliance.
• Provide support during internal audits and external regulatory inspections.
• Contribute to continuous improvement of CSV processes and templates.

Qualifications

• Bachelor's degree in Life Sciences, Computer Science, Engineering, or related field.
• 3–5+ years of experience in CSV within the biotechnology or pharmaceutical industry.
• Strong working knowledge of FDA regulations, GAMP 5, and data integrity principles.
• Experience validating GxP systems such as LIMS, QMS, ERP, or laboratory equipment with software components.
• Familiarity with cloud-based systems (e.g., SaaS platforms) and their validation challenges.
• Excellent written and verbal communication skills.
• Highly organized and able to manage multiple priorities in a fast-paced biotech environment.

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 accommodations 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 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 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.

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): $80,000 - $100,000 (compensation includes annual salary and 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.

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.

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.