Development Engineer (m/w/d)

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Beschreibung

Development Engineer (m/w/d) - Chemistry / IVD / Analytics / Laboratory / English

Role:

For our client Roche Diagnostic based in Rotkreuz we are looking for a Development Engineer (m/w/d).

Background:
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 in-process 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)

- At least 3 years of experience within an analytical laboratory

- Previous experience working in corporate R&D environment

- Experience in process development and establishing pilot scale filling lines for process

development and/or reagent production

- Hands-on experience in selecting and testing of primary packaging materials and experience

with foil is of advantage

- 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: 921043

Role: Development Engineer

Industry: Pharmaceutical industry

Workload: 100%

Location: Rotkreuz, Switzerland

Start date: ASAP

Duration: 12++

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.
Start
02/2022
Dauer
12++
(Verlängerung möglich)
Von
ITech Consult AG
Eingestellt
18.01.2022
Projekt-ID:
2292887
Vertragsart
Freiberuflich
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