Validation Engineering Lead

6 days ago


Kilkenny, Kilkenny, Ireland Asset Recruitment Full time

Asset Recruitment is a leading provider of contract recruitment services, specializing in pharmaceutical and biotechnology industries. We are currently seeking a highly skilled Senior Validation Engineer for a contract role on behalf of our client, a growing pharmaceutical manufacturer in Ireland.

Job Description

The successful candidate will join the Process Engineering Group on site and report to the Technical Engineering Manager. Primary Responsibilities include:

  • Project validation support for equipment performance qualifications (specifically cleaning and sterilization validation);
  • Authoring project validation master plans;
  • SOP and documentation updates;
  • Resolving technical issues encountered during study execution;
  • Authoring validation protocols and final reports;
  • Executing validation studies;
  • Analysis of validation data.

Main Accountabilities

  • Design/Author/Review/Approve/Execute development of change controls and qualification/validation of documentation and cycle development studies in line with the standard approval process.
  • Serve as validation representative for cross-functional projects and represent the validation team at global technical forums.
  • 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.
  • Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute cGMP practices in the performance of day-to-day activities and all applicable functions.
  • Accountable for compliance via documentation completion, risk assessments, closing out corrective actions, participation in audits and inspections.
  • Proactively highlight any issues around compliance.
  • Supporting regulatory audits and submissions as required.
  • Support continuous improvement through Lean Six Sigma methodologies.
  • May be required to perform other duties as assigned.


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