GxP Validation Analyst (CSV) - Manufacturing CQV Expert

Exalto Consulting

Dunboyne

On-site

EUR 84,000 - 113,000

Full time

10 days ago

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Job summary

Exalto Consulting seeks a Validation Analyst (CSV) for an on-site contract in Dunboyne, Ireland. You will work in a regulated manufacturing setting, applying CSV methodologies to qualification activities and system validation within GxP environments.

The role emphasizes experience with industrial equipment, QC/QA processes, and validated software tools (ValGenesis, Veeva, TrackWise). The contractor will liaise with cross-functional teams to ensure CQV delivers compliant results on schedule.

Qualifications

  • Experience with pharmaceutical or biotechnology manufacturing equipment.
  • Familiar with GMP/GxP environments.
  • Familiar with commissioning and qualification methodologies (FAT, SAT, IQ, OQ, PQ).
  • Experience with validation and quality tools (ValGenesis, Veeva, TrackWise).
  • Understanding of CSA and risk-based validation principles.

Skills

Pharma manufacturing
GxP / GMP
CQV methodologies
Sterile/aseptic environments
CSA validation principles

Tools

ValGenesis
Veeva
MasterControl
TrackWise
HP ALM
Rockwell/Allen-Bradley
Siemens
DeltaV

Job description

Exalto Consulting seeks a Validation Analyst (CSV) for an on-site contract in Dunboyne, Ireland. You will work in a regulated manufacturing setting, applying CSV methodologies to qualification activities and system validation within GxP environments.

The role emphasizes experience with industrial equipment, QC/QA processes, and validated software tools (ValGenesis, Veeva, TrackWise). The contractor will liaise with cross-functional teams to ensure CQV delivers compliant results on schedule.

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