For our customer located in Basel/Switzerland we are currently looking for a: Process Engineer (m/f/d)
- Location: CHN-Beijing
- Branch: pharma
- Duration: 6 months +
Tasks & Responsibilities
- Lead and manage all technical/laboratory/process activities and apply expertise to address complex design, development, operational issues and actively support DDC in decision making, strategies and goals by participating in cross-functional teams. Develop and implement long-term strategies on technologies, processes, medical devices and packaging related matters. Act as the Person-in-Plant (PIP) for Project-, Industrialization-, Qualification/Validation- and Supplier Management activities
- Define the strategy, process, methods and tools for establishing a control strategy from end-to-end and implement this process, methods and tools.
- Lead the establishment and implementation of best practices
- Lead the establishment of standard operating procedures, work procedures, document templates and general guidance documents
- Coordinate input to internal and external audits and inspections
- Maintain knowledge in the areas of Industrialization, Manufacturing, Checking and Control of medical devices and combination products
- Review design for manufacturing assessments, like mold flow , Design of Experiments (e.g. for OQ runs) and Design for Manufacturing and Assembly (DFMA)
- Conduct activities and pursue audits for industrialization, qualification and validation of manufacturing processes for combination products and devices with/at suppliers & partners
- Support project teams to prepare Medical Device/Combination Product pre- registration documents and provide input to answer health authority questions
- Conduct and oversee supplier management activities like Supplier Approval, Audits, Certification, Quality Risk Assessment, Quality Assurance Amendments, Evaluations, Development Agreements and supplier selection
- Lead activities to conduct CSSM tasks with suppliers & partners
- Escalate and communicate status, issues and problems within the project with the management of suppliers and partners
- Support Project leader in project management and communication activities with suppliers & partners
- Act as the Person in Plant (PiP) for the company at partners and suppliers
Did we catch your interest?
The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).