Project Engineer - Validation

TECHNICAL & ENGINEERING
TECHNICAL & ENGINEERING
Cork
Permanent
15825
Cork
Permanent
15825
Overview:

The Project Engineer will be directly involved in the validation of new equipment, providing support on process introduction and or process changes.


Role Responsibilities:

  • Drafting of documentation and Execute validations on new equipment introductions/processes/process changes. Examples include URS development/IQ/OQ/PQ+PV/Validation Plans/Risk Assessments/pFMEA/ Test Methods
  • Work in a manufacturing environment adhering to appropriate quality standards, work instructions and Health & Safety considerations.
  • Acts as a liaison to external suppliers regarding contracted products, tools & fixtures and their manufacture, acting as a technical expert or complete special projects in individual areas of expertise (i.e. programming, tooling, packaging, finishing etc.
  • Work in cross-functional project teams in order to accomplish new product implementation, process design, process improvement or any other technical manufacturing issues.
  • Drive process improvements/capacity increases through new technology/equipment introductions.
  • Prepare and maintain of relevant system specifications.
  • Identify and lead cost and technical improvements under the customer’s continuous improvement programs.
  • Provide timely and accurate reporting on project activities

 

Role Requirements:

  • Degree qualified in a relevant Engineering / Science discipline, with relevant experience in at least 2 Major Projects would be preferable
  • Experience in regulated industry, FDA, ISO, etc for Medical Devices/Pharma
  • Experience in project management utilizing organizational skills
  • Ability to lead significant projects to completion, on time and managing budget.
  • Leadership skills and the ability to make effective decisions.
  • Knowledge of Clean lines and Non-Destructive Testing Methods would be advantageous


Other Information/Additional Preferences: 

  • Knowledge of cleaning systems and In-process clean systems, pre and post clean inspection processes and execution of activities.
  • Knowledge of cleaning technologies, ultrasonic cleaning, immersion cleaning, blast cleaning.
  • Understanding of water purification generation systems.
  • Understanding of Validation and Computer Systems Validation.
  • Demonstrated qualification and background within a regulated industry. 
  • Experience of equipment procurement, cost management and schedule development.
  • Demonstrated level of problem solving and facilitation skills. 
  • Working and collaboration across multiple functional teams. 


For a confidential discussion and more information on the role, please contact Josh Barnes.

josh.barnes@collinsmcnicholas.ie

021-4911066





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