Computer Systems Validation Engineer

Join us as a Computer Systems Validation Engineer!

Join Abeona Therapeutics Inc. as a Computer Systems Validation Engineer and be part of a mission-driven organization devoted to putting patients first. In this role, you will play a crucial part in ensuring our cutting-edge health care solutions meet the highest quality standards. Work on site four days per week and one day from home, allowing you to balance your professional and personal life seamlessly while contributing to impactful projects.

With a competitive salary ranging from $80,000 to $100,000 per year (this range includes base salary and anticipated annual bonus), this position offers not only financial rewards but also the opportunity to advance your career in a supportive environment.

Collaborate with talented individuals dedicated to transforming lives through innovative therapies. You have options to participate in a great benefits package that includes Medical, Dental, and Vision insurance, 401(k) (with 4% company match), Health Savings Account, Flexible Spending Account, 160 hours of Paid Time Off per calendar year, Snack/Drink Rooms, and a Lifestyle Spending Account.

Abeona Therapeutics Inc.

- Who We Are

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.

Your day-to-day as a Computer Systems Validation Engineer

As a Computer Systems Validation Engineer at Abeona Therapeutics Inc., your day-to-day activities will center around ensuring that our computerized systems used in GxP-regulated activities-such as clinical, laboratory, manufacturing, and quality-are meticulously validated and maintained in compliance with FDA, EMA, and other global regulatory standards. You will play a critical role in collaborating closely with cross-functional teams, implementing and validating systems that are vital to our key biotech processes, from research and development through to commercial production.

Your expertise will directly impact the quality and reliability of our therapeutic solutions, all while upholding our commitment to putting patients first. This position enables you to contribute meaningfully to the advancement of gene-based therapy solutions in a compliance-focused environment.

Schedule

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

Does this sound like you?

To thrive as a Computer Systems Validation Engineer at Abeona Therapeutics Inc., a robust skill set is essential. Strong expertise in GxP computer system validation (CSV), with a thorough understanding of regulatory frameworks such as FDA 21 CFR Part 11 and EU Annex 11, is critical. Knowledge of GAMP 5 methodology and experience in developing user requirements specifications (URS), functional and design specifications, test plans, and summary reports will be key to ensuring compliance.

Proficiency in conducting risk assessments, impact analyses, and ensuring data integrity and change control will support the maintenance of high-quality standards. Familiarity with validation processes for systems like LIMS, ELN, CTMS, EDC, QMS, DMS, MES, and SCADA, along with cloud/SaaS platform validation, is highly desirable. Excellent written and verbal communication skills, along with strong project management and documentation practices, will enable you to effectively collaborate with cross-functional teams and manage compliance initiatives.

Required Qualifications

Knowledge and skills required for the position are:

* 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 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…