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Project Engineer

Engineering
Cork
Peter Paul Galligan
Contract
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Job Reference: JO-2009-65374_1599470166

Summary:

Project Engineer


12 Month FTC




Reporting to: Project Lead



Job Purpose:



The successful Project Engineer will be responsible for planning, design, coordination, validation, and implementation of high technology equipment and/or processes to support the production, finishing and inspection of delivery system products. The candidate must also demonstrate excellent analytical skills in problem solving.



Major Accountabilities - as required.



· Responsible for opening change controls and the completion of all required GxP validation assessments.


· Responsible for preparing and gaining approval for Project and Validation plans.


· Responsible for coordination and completion of Risk Management documents and generation of all validation protocols.


· Generate and execute pre-validation studies and reports as required.


· Manage and execute the equipment and process validations.


· Coordinate all associate training and release the necessary production SOPs and associated documentation.


· Change Control Closure.




Specific Position Knowledge/Skills/Abilities (Preferred and can be tailored to specific projects):



· Knowledge and experience of process engineering, equipment and automation specification.


· Knowledge of GMP validation and change control requirements.


· Knowledge of regulatory requirements of bodies such as FDA/CE/TUV


· Knowledge of data analysis by statistical methods.


· Well-developed Project Management skills


· PC and software proficiency - Microsoft software and Microsoft project


· Report writing expertise and highly developed people skills. Knowledge of process analysis and optimisation, and basic industrial engineering.


· Must also demonstrate analytical skills in problem solving.


· Attention to detail with excellent organizational skills


· Knowledge of requirements of machinery directive - i.e. CE marking



Education:



Minimum: Bachelor's degree in Engineering/ Physics or related discipline


Preferred: Masters/ PhD degree in Engineering/ Physics or related discipline



Experience:



Minimum: 3-5 year's experience in a high volume manufacturing environment with experience of process engineering and process/product introduction.


Preferred: 5-10 year's experience in medical device manufacturing executing product and process technology transfers in a regulated industry environment. Experience to include cross site projects and R&D Liaison. Project management and team leadership experience. Regulated industry experience.



Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.


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Peter Paul Galligan
Peter Paul Galligan
Talent Consultant
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