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