Job Reference: JO-2007-65307_1595336174
The selected candidate will be responsible for the clean and pack process for multiple projects with the support of existing experience clean & pack engineers in the NPI department. He/She will develop, qualify & launch the Clean & Pack process as part of the Core Team.
- Process development including PFMEA
- Process Characterisation through engineering studies
- Process Qualification/Validation
- Planning & execution of key deliverables & action plans with the help of the Project Manager
- Regular reporting on the status, performance, and risks of your project
- Participate in DFM reviews with Design Team to minimize lifecycle cost
- Minimize Environmental and Health & Safety effects of your work
- Adhere to the company's procedures as detailed in the SOP manual
- Support Regulatory Affairs with product submissions
- All other duties as directed by direct manager
The ideal candidate would be a planned and organised individual with strong technical or process knowledge/experience in cleaning & packaging within a regulated industry. A strong team player that will own the delivery of elements within their process/technology area. You will need strong interpersonal skills, be able to collaborate effectively to resolve technical challenges. Knowledge/experience in sterility assurance is an advantage.
- Third level degree in Engineering or similar discipline.
- 1-3 years' experience in equipment installations/facilities/commissioning
- Self-motivated, with a focus on H&S, Quality, Delivery, and Cost.
- Proven Root Cause analysis and problem-solving techniques
- 1-3 years' experience in equipment operation/installation/qualification in a regulated environment.
- Exposure to Project Management methodologies
- Knowledge of medical device or pharmaceutical industries
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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