Job Description

JOB TITLE: Computer System Validation Engineer

DESCRIPTION

POSITION OVERVIEW

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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