Computer Systems Validation Engineer

Abeona Therapeutics Inc. • Cleveland, OH

1d • Hybrid

About The Position

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.

Requirements

• 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.
• 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.

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.

Benefits

• Medical insurance coverage (multiple options to meet our employees' and their families' needs)
• Dental and vision coverage
• 401k match plan
• Lifestyle spending account
• 160 hours of paid time off per calendar year (Prorated based on date of hire; can carry 40 hours over to the next year)

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level