• Computer System Validation Engineer

    Abeona (Cleveland, OH)


    Job Description

    JOB TITLE: Computer System Validation Engineer

     

    Department: Validation

     

    Reports to: Director of Validation

     

    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.

    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

    • Primarily a desk-based role with prolonged periods of computer use.

    • Occasional work in laboratory, cleanroom, or manufacturing environments may be

     

    required.

     

    • Ability to occasionally lift and carry items up to 25lbs (e.g., laptops, documentation

     

    binders, or small equipment).

     

    • 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.

     

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