Validation Analyst (CSV) - Ireland - £450 per day - 6 months

Exalto Consulting; Dunboyne; Vor Ort; EUR 84.000 - 113.000; Vollzeit

Zusammenfassung

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.

Qualifikationen

• 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.

Kenntnisse

Pharma manufacturing

GxP / GMP

CQV methodologies

Sterile/aseptic environments

CSA validation principles

Tools

ValGenesis

Veeva

MasterControl

TrackWise

HP ALM

Rockwell/Allen-Bradley

Siemens

DeltaV

Jobbeschreibung

Validation Analyst (CSV) - Dunboyne (Ireland) on site - contract - £450 per day

Exalto consulting are recruiting for a contract Validation analyst to work within manufacturing environment, you will be working with systems in regulated (GxP) and GMP environments.

Preferred Skills

• Experience with pharmaceutical or biotechnology manufacturing equipment, including bioreactors, chromatography skids, filtration systems, filling equipment, packaging lines, autoclaves, and cleaning systems.
• Experience with manufacturing automation platforms such as Rockwell Automation/Allen-Bradley, Siemens, Emerson DeltaV, or comparable technologies.
• Familiarity with commissioning and qualification methodologies, including FAT, SAT, DQ, IQ, OQ, PQ, and integrated CQV approaches.
• Experience supporting sterile or aseptic manufacturing environments and knowledge of relevant EU GMP Annex 1 requirements.
• Understanding of manufacturing process validation, CPPs, CQAs, and process performance qualification.
• Experience with validation and quality management tools such as ValGenesis, Veeva, MasterControl, TrackWise, HP ALM, or comparable platforms.
• Knowledge of ISPE Commissioning and Qualification guidance, ASTM E2500, and science- and risk-based qualification methodologies.
• Familiarity with Computer Software Assurance (CSA) principles and risk-based validation methodologies.

Validation Analyst (CSV) - Dunboyne (Ireland) on site - contract - £450 per day