Development Engineer

Beschreibung

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)
instruments. 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 (e.g. 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.