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Development Engineer

ITech Consult

Posted on Nov 17, 2021 by ITech Consult

Zug, Switzerland
Research
Immediate Start
Annual Salary
Contract/Project

Development Engineer - R&D environment, testing of materials, IVD reagents, chemical analytical methods IC, UV/VIS or ICP-MS)

Role:
For our client in the Pharma industry based in Rotkreuz we are looking for a Development Engineer.

We are looking for a chemical/process engineer to support our System Reagents Subchapter in the Sensor and Reagent Development Chapter of the R&D Point-of-Care Network dedicated to the development of Blood Gas & Electrolytes (BGE) solutions. BGE System Reagents Subchapter is one of the groups within the Point-of-Care R&D Sensor and Reagent Development Chapter at RDI Rotkreuz. It is a multidisciplinary and multicultural team with expertise in development of the reagents (calibrators, controls, diluents, internal solutions) as well as in the reagent packaging for Roche Blood Gas & Electrolytes (BGE) nstruments. The subchapter covers the following areas of expertise: Development of IVD reagents (calibrators, controls and internal solutions) for BGE systems in a lab-lot scale, Development of primary and secondary packaging materials, Evaluation of reagent, sensor and material compatibilities, Establishing a pilot scale reagent filling line, Development of inprocess control and release test methods, Establishment of reagent and raw material specifications and requirements, Transfer of the reagent formulation and process to Operations, Support of Operations and Regulatory Affairs and Providing product care for all system fluids in BGE systems. We work in close cooperation with other BGE R&D teams, Operation's Reagent Process Improvement, Reagent Production and Quality Control teams.

Areas of responsibility:
* Development of reagent formulations in a lab-lot scale
* Selection and testing of primary packaging and secondary materials
* Establishing and optimizing a pilot scale filling line for lab-lot production
* Evaluation of the chemical stability, sensor and material compatibility of formulations with different analytical techniques
* Establishing and maintaining close collaborations with other teams such as system engineering, method development, system testing and Operations or external partners
* Coordination of reagent and material analysis in external laboratories according to standards; evaluation of test results
* Timely and efficient documentation of test results; preparation of test plans and test reports
* Coordination of project deliverables and tasks according to timelines

Professional and technical requirements:
* Academic degree in Chemistry, Chemical or Process Engineering or Material Science
* At least 3 years working experience within a relevant industry. IVDR experience is of advantage
* Previous experience working in corporate R&D environment
* Hands-on experience in selecting and testing of primary packaging materials experience with foil is of advantage
* Experience in process development and establishing pilot scale filling lines for process development and/or reagent production
* Experience in the development of IVD reagents in a regulated environment and the assessment of chemical stabilities
* Broad knowledge and hands-on experience in chemical analytical methods (eg HPLC/IC, UV/VIS or ICP-MS) with focus on small molecules and ion analytics
* Willingness to work in a S2 lab environment
* Excellent technical writing skills
* Excellent communication and collaboration skills, ability to collaborate and network with people across R&D, Operations and Quality Assurance
* Solution oriented, open-minded, autonomous and proactive working style
* Fluent in English, German is of advantage

Reference no: 920860 AD
Role: Development Engineer
Industry: Pharmaceutical industry
Workload: 100%
Location: Rotkreuz, Switzerland
Start date: ASAP
Duration: 12 months contract, with possible extension

About us:
ITech Consult is a certified ISO 9001:2015 Swiss company with offices also located in Germany and Ireland. ITech Consult is specialised in delivering IT candidates for contract work. We were founded in 1997 by IT professionals; hence we well understand what it means to be professionally supported in your search for a new project and being employed.

Reference: 1402551402

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