Validation Engineers – Hybrid (NHMC01)

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Validation Engineers – Hybrid roles

We are currently offering fantastic Engineering Specialist (Validation) opportunities for candidates interested in a new challenge in a cGMP regulatory environment. The successful candidates will support several aspects of Validation.  The roles available that will require experienced, energetic and committed engineers are in the following areas:

  • 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

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.
  • 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).

Qualifications and Experience:

  • Relevant technical qualification(s) in Applied Pharmaceutical / Biological / Chemical sciences or applied Technical / Engineering qualification, the successful candidate will also have a proven track record in delivering excellence.
  • Knowledge of CTU equipment qualification.
  • Knowledge of thermal mapping equipment.
  • Thermal mapping skills.
  • Exception / Deviation Management and Change Control.
  • Demonstrable experience of leading technical related projects.
  • Knowledge of process monitoring systems, automation systems (DeltaV), operational intelligence & data systems (Pi System) within a GMP manufacturing environment would be beneficial and desirable.
  • Equipment and process validation.
  • Sterile Fill-Finish processes and equipment.
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