The successful candidate will support several aspects of Validation: predominantly Isolator and Filling Line qualification and studies.
- 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 firstname.lastname@example.org
|Job Category||Validation Engineer|