Beschreibung
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 required
-German a plus, not a must
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!