16165 – Validation Engineer – Carlow Contractor

This is an 11-month contract.

Purpose

The successful candidate will support several aspects of Validation: predominantly Isolator and Filling Line qualification and studies.

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

Requirements

• 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 HVAC systems
• Knowledge of Isolator VHP qualification
• Knowledge of Sterilisation processes for Isolators
• Thermal mapping skills
• Exception / Deviation Management and Change Control.
• Demonstratable experience in 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 analyze 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.
• 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.
• 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
• Controlled Temperature Units/Equipment Qualification
• Vial and Syringe Processing Technologies