Michael Page
The primary function of this position is the day-to-day running of the Packaging Test Centre in addition to supporting sustaining Engineering activities such as test engineering studies testing, design verification testing, laboratory instrumentation and equipment control, samples management, database administration. Additionally, the incumbent can support other engineering developmental tasks as required. The incumbent will interface directly with personnel from different departments. The main objective is to ensure resolution of all operational-technical issues and timely implementation of all projects, while maintaining compliance to cGMP's and all regulations.
- Run the Packaging Test Centre supporting Packaging Design and Development activities.
- Support Device Stability activities pertaining to shelf life or expiration dating.
- Support new product development activities and ongoing manufacturing operations support programs.
- Perform well designed test methods and basic manufacturing processes according to specific written directions to ensure the end products function as intended over its shelf life.
- Utilize laboratory, manufacturing and measuring equipment as per written procedures and training.
- Utilize software applications to correspond to team members, order materials, process data, register results and generate documentation, and comply with cGMP.
- Work within appropriate project guidelines with respect to deadlines in order to support new product functions or implementation of new processes or materials for drug containers and packaging.
multinational medical device company
- Bachelor's degree in scientific subjects (engineering, physics, chemistry) - and/or University Student in Engineering Area
- Experience Related technical work within manufacturing site Technical, engineering and/or development process. Technical laboratory testing, Maintenance, Quality testing, Documentation skills.
Other:
- Working knowledge of ISO 11607-1 (Packaging for Terminally Sterilized Medical Devices - Requirements for Materials, Sterile Barrier Systems and Packaging Systems).
- Working knowledge of ISO 11607-2 (Packaging for Terminally Sterilized Medical Devices - Validation Requirements for Forming, Sealing and Assembly Processes).
- Working and Testing knowledge of ASTM Testing related to Medical Device Sterile Packaging. To include ASTM D4169, ASTM D4332, ASTM F2825 etc. etc.
- Working knowledge of Accelerated Aging and Real Time aging in accordance with ASTM F1980
- Working knowledge of ISO 15223-1 (Medical Devices - Symbols to be used with Medical Device Labels, Labeling, and Information to be Supplied).
- English Level: B2/C1
Settore: Altro
Ruolo: Ingegneria/Progettazione