12 Month FTC
Reporting to: Project Lead
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
Minimum: Bachelor's degree in Engineering/ Physics or related discipline
Preferred: Masters/ PhD degree in Engineering/ Physics or related discipline
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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