Production Engineer

Job content

Production Engineer (m/f/d) – Change Management / ISO 13485 / SAP / Document Management / English

Project:

For our customer Roche Diagnostics International AG based in Rotkreuz we are looking for a Production Engineer (m/f/d)

Background:

Instrument Operations Rotkreuz ensures the production and management of a complex portfolio of small to large analysis systems.

Within this organization, the Production Engineering department is a support department with various teams that support the assembly, quality control, technical approval and packaging of the diagnostic devices. The aim is to support production in the best possible way in order to ensure smooth processes and the highest quality and quantity.

As one of these teams, the Production Engineering team is responsible for the implementation and coordination of technical change requests (change management). In order for changes to be implemented smoothly, the individual steps of the change must be planned, the risk of the change must be assessed and justified, tasks must be communicated and implemented with the relevant stakeholders, and the change must be verified/validated.

The ideal candidate is a person with a very high quality awareness who enjoys working with a wide variety of interfaces in a large organization and for whom precise documentation is a matter of course.

In-depth technical know-how and experience in a regulated environment are just as much sought-after skills as project management and excellent stakeholder communication. It is also important to question things critically and to be willing to learn new things.

Main tasks and areas of responsibility:

* Change management: planning, coordination and implementation of changes in consultation with the product leader and lead PE

* Responsible for the smooth entry and exit control of changes in production without affecting production performance and quality

* In-depth knowledge of the assigned products

* Technical assessment of change requests and the use of components and assemblies in the event of transport

damage * Creation and maintenance of specification and verification documents for product manufacture as well as work plans, material master data and parts lists

* Implementation of training courses (specification and verification documents for product manufacture)

* Participation in the creation and revision of technical delivery conditions

* Support of the technical supplier management and production with troubleshooting or Corrective measures

* Project work or project management as instructed by the team leader

* Active support in the implementation of improvement measures (CIP) and permanent optimization of work processes and processes to increase quality and efficiency

* Compliance with the applicable regulations, especially with regard to occupational safety, GxP and ISO 13485

* Technical examination of verification/validation documentation

Must haves:

* Technical training / technical college (minimum HF degree or comparable technical training/further training)

* First professional experience in change management or in project and process management

* Practical experience in a regulated GxP environment, ideally in medical technology or IVD (ISO 13485, FDA 21 CFR 820, IVDR/MDR)

* First professional experience in document management

* First user knowledge in SAP or a comparable ERP system

* Very good user knowledge in MS Office and Google applications

* Very good communication skills in German and English (spoken and written) is required

* Ability to work in a team, Independent and reliable way of working is expected.

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Reference No.: 921974TP

Role: Production Engineer

Industry: Pharma

Place of work: Rotkreuz

Workload: 80-100%

Start: 11/16/2022

Duration: 12++

Application deadline : 09/28/2022

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If this position has aroused your interest, please send us your complete dossier via the link in this advertisement. If this position does not fit your profile so well and you would like to get another position directly, you can also send us your dossier via this advertisement or to jobs[at]itcag[dot]com.

Contact us for more information about our company, our positions or our attractive payroll-only program: +41 41 760 77 01.

About us :

ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specializes in the placement of highly qualified candidates for personnel leasing in the areas of IT, Life Science & Engineering.

We offer staff leasing & payroll services. This is free of charge for our candidates, and we do not charge you any additional fees for Payroll either.