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Project Engineer (Validation)

Engineering
Cork
Abeer Ansari
Permanent
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Job Reference: JO-2008-65334_1597917214

Summary:


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 in regard to 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 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


The below skills will give emphasis to the cleaning/inspection requirements of the role.



  • 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 the requirements around sanitization and sterilization processes.

  • Understanding of Validation and Computer Systems Validation.

  • Demonstrated qualification and background within a regulated industry.

  • Experience in equipment procurement, cost management, and schedule development.

  • Demonstrated level of problem-solving and facilitation skills.

  • Working and collaboration across multiple functional teams.

  • Change management, Risk Management, Quality Management skills

  • Demonstrated qualification and background within a regulated industry.


Requirements:



  • Degree qualified in a relevant Engineering / Science discipline, with relevant experience in at least 2 Major Projects would be preferable

  • Experience in a 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



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