Validation Engineer

Validation Engineer
RK26044
Contract 11 months
Carlow




We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.




Key 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.

• 3-5 years direct experience with a pharmaceutical or biotechnology company
• Bachelor’s degree (or higher) in Biological Sciences/Chemical Engineering/Biological Engineering/Chemistry etc.
• Strong experience in CTU equipment qualification, thermal mapping, equipment/process validation, and sterile fill-finish processes within GMP manufacturing environments.
• Skilled in deviation/change control management, technical project leadership, complex data analysis, and linking equipment performance to out-of-specification findings.
• Knowledge of GMP process monitoring, automation and data systems (e.g. DeltaV, PI System), regulatory/code compliance, and technical report/policy writing.