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. Powered by JazzHR MvZGvwaTCM