Computer Systems Validation Engineer
About The Position
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. Schedule: This position is scheduled Monday to Friday from 9:00 AM to 5:00 PM. This position is onsite but allows up to 1 day of remote work per week (depending on department priorities)
Requirements
- 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.
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.
Benefits
- Medical insurance coverage (multiple options to meet our employees' and their families' needs)
- Dental and vision coverage
- 401k match plan
- Lifestyle spending account
- PTO: 160 hours of paid time off per calendar year (Prorated based on date of hire; can carry 40 hours over to the next year)
- Compensation (annual): $80,000 - $100,000 (compensation includes annual salary and the anticipated annual bonus)
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
11-50 employees
