Validation Engineer

Our site are excited to offer a fantastic Engineering Specialist (Validation) opportunity for candidates interested in a new challenge in a cGMP regulatory environment. The successful candidates will support several aspects of Validation. The role available that will require experienced, energetic and committed engineers in the following areas:

Isolator (Filling, Sterility & Material Transfer isolators) - HVAC, VHP, E-Beam and Depyrogenation systems

Role Functions:

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• 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.
  
• Work collaboratively to drive a safe and compliant culture.
  
• May be required to perform other duties as assigned
  

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• In order to excel in this role, you will more than likely have considerable experience in a comparable role, with experience operating as individual contributor adding value to the business in a GMP manufacturing setting, as well as the following qualifications/skills:
  
• 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 in delivering excellence.
  
• 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.
  
• Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable
  
• Evidence of continuous professional development is desirable.
  
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.
  
• 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.
  
• Proficiency in Microsoft Office and job-related computer applications required
  
• Excellent communication, presentation and interpersonal skills, to interface effectively with all levels of colleagues and with external customers in a team orientated manner.
  

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• Equipment Periodic Validation
  
• Equipment Validation Lifecycle
  
• Project Management Skills/Qualification
  
• Filter Validation & Container Closure Validation
  
• Isolator Qualification
  
• Vial and Syringe Processing Technologies
  
• Temperature Mapping
  
• Cleaning Validation
  
• The successful candidate will be required to work both independently and in a cross-functional team to accomplish validation project objectives. Works with moderate work direction and is skilled and knowledgeable to the position. xcfaprz
  

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• 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 in delivering excellence.