Computer System Validation (CSV) Engineer
Katalyst Healthcares and Life SciencesBoston, MA, United States30+ days ago
Job type
- Full-time
Job descriptionBachelor's degree in computer science, Engineering, Life Sciences, or related field. 2+ years of hands-on CSV experience in pharma, biotech, or medical device environments. Strong working knowledge of GxP, FDA regulations, and SDLC methodologies. Experience validating cloud-based or SaaS GxP systems is a plus. Excellent documentation, communication, and collaboration skills.
Responsibilities :
- Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc.
- uthor and maintain validation deliverables : URS, FS, DS, IQ, OQ, PQ, and traceability matrices.
- Ensure systems comply with 21 CFR Part 11, EU Annex 11, and GAMP 5.
- Support system implementations, upgrades, and periodic reviews.
- Collaborate with QA, IT, and business users to drive validation strategy.
- Participate in audits and inspections to demonstrate compliance.
Requirements :
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Validation Engineer • Boston, MA, United States
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