Validation Engineer
Reference: SMC19759
Location: Cork
Qualification: Degree
Experience: 3-4 Years
Job Type: Fixed Term Contract
Salary: Not Disclosed
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.
Duties: 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. Experience and Education: Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification.3-5 years' industry experience.Knowledge of CTU equipment qualification, thermal mapping equipment.
If interested in this posting please feel free to contact Rachel Kent on +353 (0)87 427 8808 or ****** for further information.
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