This is an 11-month contract initially.
The successful candidates will support several aspects of Validation. The roles available that will require experienced, energetic, and committed engineers are in the following areas: Sterilisation – Autoclaves, SIP of vessels, Cleaning – Parts Washer and CIP of vessels Isolator (Filling, Sterility & Material Transfer isolators) – HVAC, VHP, E-Beam and Dehydrogenation systems, Controlled Temperature Units (CTU) – Temperature/Humidity Mapping, Filter Validation.
• 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.
• Resolving technical issues encountered during study execution.
• Engagement with Production, Maintenance, and Quality representatives in the assigned area of operations during the execution of Cycle Development and Performance Qualification activities.
• Technical input into quality notification by authoring/reviewing/approving investigations.
• Perform root cause analysis of system failures, and 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.
• Drive compliance of Global Policies, Procedures and Guidelines, and regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions, ensuring
consideration of the impact on GMP and compliance and decisions made.
• 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.
• Work collaboratively to drive a safe and compliant culture in Carlow.
• May be required to perform other duties as assigned.
Knowledge and experience of the below areas will be considered advantageous
• Equipment Periodic Validation
• Equipment Validation Lifecycle
• Project Management Skills/Qualification
• Filter Validation & Container Closure Validation
• Autoclave/SIP Sterilisation Validation
• Dry Heat Sterilisation
• Isolator Qualification
• Vial and Syringe Processing Technologies
• Temperature Mapping
• Cleaning Validation
• Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification, the successful candidate will also have a proven track record of delivering excellence.
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