Biotech Engineer Specialist

1 week ago


Dublin, Dublin City, Ireland TN Ireland Full time
Job Description

We are seeking a skilled Biotech Engineer Specialist to join our team at TN Ireland. In this role, you will support various aspects of validation, including Sterilisation – Autoclaves, SIP of vessels, Cleaning – Parts Washer and CIP of vessels, Isolator (Filling, Sterility & Material Transfer isolators) - HVAC, VHP, E-Beam and Depyrogenation systems, Controlled Temperature Units (CTU) – Temperature/Humidity Mapping, Filter Validation, and Container Closure Integrity Validation.

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.


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