Abeona Therapeutics
Computer System Validation Engineer
Abeona Therapeutics, Cleveland, Ohio, United States, 44101
Computer System Validation Engineer
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. 35+ 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.
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. 35+ 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.