11 month contract
Validation Engineer
On site Carlow
AMC22979


We are currently hiring for a Validation Engineer role with a rapidly expanding biopharmaceutical manufacturer based in Carlow. In this role you will support various areas of validation on site including Sterilization, cleaning, isolators, CTU, filter and Container closure validation


The ideal candidate will have 2+ years of experience in validation of sterile fill finish processes and equipment and a relevant degree

Responsibilities

• 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 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
• Drive compliance of Global Policies, Procedures and Guidelines, 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.

• Relevant technical degree
• Knowledge of CTU equipment qualification
• Knowledge of thermal mapping equipment
• Thermal mapping skills
• Exception / Deviation Management and Change Control.
• Demonstratable experience of leading technical related projects.
• Ability to analyse and interpret complex data, and link to equipment performance and out of specification findings as appropriate.
• Report, standards, policy writing skills required.
• Equipment and process validation.
• Sterile Fill-Finish processes and equipment.

• Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment
• Evidence of continuous professional development
• Ability to analyse and interpret complex data, and link to equipment performance and out of specification findings as appropriate.

• 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