CSV - Laboratory Equipment

6 days ago

Caguas PR, United States EB Validation Services Full time $60,000 - $120,000 per year

CSV - Laboratory Equipment

Job Overview

We are seeking a motivated and detail-oriented Computer System Validation (CSV) to support validation activities for laboratory equipment and computerized systems in compliance with regulatory standards (GxP, FDA 21 CFR Part 11, EU Annex 11). The successful candidate will be responsible for planning, executing, and documenting all validation deliverables throughout the system lifecycle.

Responsibilities:

  • Develop and maintain Validation Plans and Validation Plan Reports.
  • Create and execute IOPQ Protocols (Installation, Operational, and Performance Qualification).
  • Prepare Change Control documentation and ensure proper implementation.
  • Manage Traceability Matrices to ensure full requirement coverage.
  • generated & Execute CSV documents.
  • Coordinate Release Activities for validated systems.
  • Collaborate with vendors for Vendor Support during qualification and issue resolution.
  • Ensure all validation deliverables comply with internal procedures and regulatory requirements.
  • Provide support during audits and inspections.

Qualifications:

  • Bachelor's degree in Sciences Computer Science.
  • 2+ years of experience in CSV or Equipment Qualification in a GxP-regulated environment (pharma, biotech, medical devices).
  • Solid understanding of GAMP 5, 21 CFR Part 11, and Annex 11.
  • Experience with laboratory instruments and associated software (e.g., LIMS, Empower, chromatography systems) preferred.

Skills:

  • Experience with Change Control systems and Quality Management Systems (QMS).
  • Familiarity with risk assessment methodologies (FMEA, Risk Matrix).
  • Ability to work independently and collaboratively in cross-functional teams.

Job Type: Contract

Work Location: In person

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