Work with NPI and interact with H&S, Quality, Operations, Product Design and global packaging teams to develop this process to market launch. 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. You 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:
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.
- Good experience in equipment installations/facilities/commissioning
- Self-motivated, with focus on H&S, Quality, Delivery and Cost.
- Proven Root Cause analysis and problem-solving techniques
- Good experience in equipment operation/installation/qualification in a regulated environment.
- Exposure to Project Management methodologies
- Knowledge of medical device or pharmaceutical industries