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Process Engineering Representative in Devices/Combination Products Development (m/f)

Eingestellt von Hays aus Mannheim, Universitätsstadt

Gesuchte Skills: Engineering, Design

Projektbeschreibung

REFERENZNUMMER:

237130/11

IHRE AUFGABEN:

-Represent the department (Devices, Pre-Filled Syringes Development Department) in 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
-Ensure availability of adequate materials for clinical studies
-Prepared, aligned and active participation at project team meetings. Increase awareness of critical issues and escalate 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, incl. Due Diligence.
-Design, develop, optimize, customize and/or integrate equipment and processes.
-Investigate risk/failure and resolve design/process issues and evaluate and implement change
-Qualify equipment and validate manufacturing processes as well perform design transfer, technical transfer
-Determine process variables and -controls, and 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

IHRE QUALIFIKATIONEN:

-Mechanical engineering, Device development/manufacturing, Polymer processing (injection moulding), Primary/Secondary

Packaging -Process Engineering and Project Management and Business Processes oriented
-Experienced with Medical Devices and Combination Products regulations
-Agility to work in multiple areas, cultural networks (Drug product and Devices Development - Manufacturing - Regulatory - Europe/USA )

WEITERE QUALIFIKATIONEN:

Project manager, Quality manager

Projektdetails

  • Einsatzort:

    Basel, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    9 MM++

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Hays

  • Straße:

    Willy-Brandt-Platz 1-3

  • Ort:

    68161 Mannheim, Universitätsstadt, Deutschland