Computer Systems Validation Engineer

Job Description

Job Description

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 (based on relevant experience/background, PLUS an additional discretionary 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 AreOur 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 EngineerAs 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 end-to-end 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.Essential Duties and ResponsibilitiesDevelop 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.Required QualificationsKnowledge 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 end-to-end 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, and 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 DemandsThe 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 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.Important Notes for CandidatesVisa Sponsorship Not Currently AvailableApplicants 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 DisclaimerWe'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 CSV Engineering skills to the next level and join a team that values hard work and changing lives - complete our application today!