Validation Engineer, Carlow

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 forumsDrive 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 complianceSupporting regulatory audits and submissions as required.


Education and Experience:

3-5 years direct experience with a pharmaceutical or biotechnology companyBachelor’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.


If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.