Validation Engineer

Contract
Leinster
Posted 1 month ago

The successful candidate will support several aspects of Validation: predominantly Isolator and Filling Line qualification and studies.

 

Responsibilities

  • Resolving technical issues encountered during study execution.
  • Engagement with Production, Maintenance and Quality representatives in the assigned area of operations during execution of Cycle Development & Performance Qualification activities.
  • Technical input into quality notification by authoring/reviewing/approving investigations.
  • Perform root cause analysis of system failures, substandard performance, using standard tools and methods, to resolve machine and system issues.
  • Support continuous improvement through Lean Six Sigma methodologies.
  • Serve as validation representative for cross functional projects and represent the validation team at global technical forums
  • Accountable for compliance via documentation completion, risk assessments, closing out corrective actions, participation in audits and inspections and proactively highlighting any issues around compliance
  • Supporting regulatory audits and submissions as required.
  • Design/Author/Review/Approve/Execute qualification/validation documentation and cycle development studies in line with the standard approval process.
  • Design/Author/Review/Approve/Execute Execution/development of change controls.
  • Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable
  • Ability to analyse and interpret complex data, and link to equipment performance and out of specification findings as appropriate.
  • Equipment and process validation.
  • Sterile Fill-Finish processes and equipment.
  • Equipment Periodic Validation
  • Equipment Validation Lifecycle
  • Project Management Skills/Qualification
  • Filter Validation & Container Closure Validation
  • Autoclave/SIP Sterilisation Validation
  • Dry Heat Sterilisation
  • Controlled Temperature Units/Equipment Qualification
  • Vial and Syringe Processing Technologies

 

Qualifications & Education

  • Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification
  • Knowledge of HVAC systems
  • Knowledge of Isolator VHP qualification
  • Knowledge of Sterilisation processes for Isolators
  • Thermal mapping skills
  • Exception / Deviation Management and Change Control.
  • Demonstratable experience of leading technical related projects.

 

To apply contact Martin Lynch on 087-344 3581.

 

Email CVs to mlynch@mile.ie

Job Features

Job CategoryValidation Engineer

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