Computer System Validation (CSV) Engineer Job at Katalyst Healthcares & Life Sciences, Newton, MA

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  • Katalyst Healthcares & Life Sciences
  • Newton, MA

Job Description

  • Katalyst Healthcares & Life Sciences is hiring entry level candidates for several positions for contract research in Clinical trials of drugs, biologics and medical devices.
  • We have a few immediate job opportunities available in Drug Safety and Pharmacovigilance and Clinical Research field. We work with University hospitals, pharmaceutical companies and recruiting partners.

Job Description



Responsibilities:

  • Lead and execute CSV activities across GxP-regulated systems (LIMS, MES, ERP, etc.
  • Author 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:

  • Bachelor'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.

Additional Information



All your information will be kept confidential according to EEO guidelines.

Job Tags

Contract work, Immediate start,

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