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Job Description

JOB TITLE: Computer System Validation Engineer

Department:

Validation

Reports to:

Director of Validation

Role 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 (clinical, laboratory, manufacturing, quality) are validated and maintained in compliance with FDA, EMA, and other global regulatory standards. This involves collaboration with cross-functional teams to implement, validate, and sustain systems supporting biotech processes from R&D through commercial production.

Essential Duties and Responsibilities

1. Develop and execute validation deliverables for GxP systems aligned with regulatory guidelines (21 CFR Part 11, EU Annex 11, GAMP 5).
2. Partner with system owners, QA, IT, and vendors to define User Requirements Specifications (URS), ensuring traceability through Functional and Design Specifications, Test Plans, and Summary Reports.
3. Lead CSV efforts for systems supporting biotech processes such as laboratory systems (LIMS, ELN), clinical trial management systems (CTMS, EDC), quality systems (QMS, Document Management Systems), and manufacturing systems (MES, SCADA).
4. Conduct risk assessments and impact analyses to develop validation strategies.
5. Ensure documentation practices meet internal SOPs and inspection standards.
6. Support change control processes, periodic reviews, revalidation efforts, and data integrity compliance.
7. Assist during internal audits and external regulatory inspections.
8. Contribute to continuous improvement of CSV processes and templates.

Qualifications

• Bachelors degree in Life Sciences, Computer Science, Engineering, or related field.
• 35+ years of CSV experience in biotech or pharmaceutical industries.
• Strong knowledge of FDA regulations, GAMP 5, and data integrity principles.
• Experience validating GxP systems like LIMS, QMS, ERP, or laboratory equipment with software components.
• Familiarity with cloud-based systems (SaaS platforms) and validation challenges.
• Excellent communication skills.
• Highly organized with the ability to manage multiple priorities in a fast-paced biotech environment.

Physical Demands

• Primarily desk-based with prolonged computer use.
• Occasional work in laboratory, cleanroom, or manufacturing environments.
• Ability to lift and carry items up to 25 lbs.
• May require PPE in GMP or lab areas.
• Occasional walking, standing, or stairs; travel between sites or vendors may be needed.

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