End-to-End Laboratory Validation Specialist

Next Generation

Tipperary

On-site

EUR 70,000 - 90,000

Full time

9 days ago
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Job summary

Next Generation in Ireland seeks a Laboratory Validation Specialist to own the installation, qualification, CSV and decommissioning of analytical instruments across development and commercial labs. You will lead IQ/OQ/PQ studies, author validation master plans and coordinate vendor engineers, ensuring SDLC compliance and data integrity across instruments.

This role offers end-to-end ownership from purchase to validated release, supporting laboratories across drug substance and drug product

Qualifications

  • Degree in analytical chemistry or related science; GMP environment experience preferred.
  • Hands-on validation of laboratory equipment and instruments.
  • CSV/LIMS validation experience and data integrity knowledge.
  • Experience with instrument control software and documentation practices.
  • Strong technical writing and SOP development skills.

Responsibilities

  • Lead installation and decommissioning of laboratory instruments.
  • Develop IQ/OQ/PQ protocols and master plans for instruments.
  • Execute equipment qualification studies (IQ/OQ/PQ).
  • Carry out CSV on software-controlled instruments and data reviews.
  • Coordinate vendor service engineers on site.
  • Update SOPs and supporting documentation; support audits.

Education

Analytical chemistry degree

Tools

Empower
LIMS
Asset management systems

Job description

Next Generation in Ireland seeks a Laboratory Validation Specialist to own the installation, qualification, CSV and decommissioning of analytical instruments across development and commercial labs. You will lead IQ/OQ/PQ studies, author validation master plans and coordinate vendor engineers, ensuring SDLC compliance and data integrity across instruments.

This role offers end-to-end ownership from purchase to validated release, supporting laboratories across drug substance and drug product

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