Description
Randstad Professionals is actively looking to find an open-minded and motivated candidate to join our client in Basel, Switzerland.
We are looking for a Process Engineer in Devices/combination Products Development to support our client's team in the area of product development.
Accountabilities, responsibilities and activities:
Technical:
- Represent PTDE-D (Devices, Pre-Filled Syringes Development Department) in the Device Team and other decision making groups, providing high quality expertise.
- Define costs and resource needs/timely and quality completion of activities contributing to technical deliverables.
-Prepared, aligned and active participation at project team meetings. Increase awareness of critical issues and forward to Line Function management and to decision making groups.
-Develop device manufacturing strategy with partners and stakeholders. Establish technical product requirements to assure devices maintain performance of the product they intend to deliver.
-Assess, evaluate and innovate device manufacturing equipment and processes to determine appropriate candidates (including Due Diligence).
-Design, develop, optimize, customize and/or integrate equipment and processes. Investigate risk/failure and resolve design/process issues. Evaluate and implement change.
-Qualify equipment and validate manufacturing processes, perform design transfer, technical transfer.
-Determine process variables and controls. Identify Critical Process Parameters. Establish control strategy.
-Provide technical, specification, design control (Design Development Plan (DDP), User Requirements(URS))
-Collaborate effectively with partners in Technical Research and Development, Quality, Commercial Manufacturing in developing aligned strategies and concepts for the development of Combination Products for Biologics. Act as Ambassador for Device Development.
-Comply with internal and external requirements in all aspects of operations.
-Act in compliance with Pharmaceutical Quality System, local Standard Operating Procedures, Corporate Values and Behaviour, Our client's Health and Safety requirements
Business Processes:
-Participate or lead actively the review and improvement of our Device Development Process Engineering related Business processes.
Required competencies
-Mechanical engineering, Device development/manufacturing, Polymer processing (injection moulding), Primary/Secondary Packaging,
-Process Engineering
-Medical Devices and Combination Products regulations
-Business Processes oriented
-Agility/working in multiple areas/cultural network (Drug product and Devices Development/
Manufacturing/Regulatory/Europe/USA)
-Project Management
Languages
-English spoken as minimum
-German spoken is nice to have
This is a contracting position for an 8 months +
If this role excites you, and you feel you could take this next challenge in your career, then don't hesitate to send your application.
Good to know you!