eLIMS Site key user

At Johnson & Johnson, we believe health is everything.

Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function:
Quality

Job Sub Function:
Quality Control

Job Category:
Professional

All Job Posting Locations:
Beerse, Antwerp, Belgium, Gent, East Flanders, Belgium, Zwijnaarde, Belgium, Zwijnaarde, East Flanders, Belgium

Job Description:

CAR-T is an innovative blood cancer treatment that uses the strength of the patient's own immune system.

The patient's T-cells are genetically modified to eliminate the cancer cells.

This advanced technology offers hopeful prospects to patients for whom other therapies provide no or insufficient results.

We are therefore working passionately on expanding our capacity for CAR-T treatments in Europe, both at our existing site in Beerse and in Ghent, where we have developed a new production site.

We are looking for strong talents who are eager to participate in this innovative and hopeful venture.

The Innovative Medicine Supply Chain Group, a member of the Johnson & Johnson family of companies, is therefore recruiting an eLIMS SKU for the CAR-T hub in Europe.

The position will be based in Beerse Belgium.

The eLims SKU, CAR-T Europe is responsible for providing first line eLims/iLabs support for Ghent & Beerse.  They will be responsible for drawing eLims set-up including LME / reagent module & instrument module set-up for the Ghent & Beerse labs in accordance with Janssen policies, standards, procedures, and Global cGMP’s.  

Major Responsibilities:


* Act as first line support for Ghent & Beerse in case of any eLims/iLabs issues.


* Maintain eLims set-up for analysis performed at the Ghent and Beerse labs, including spec, sample plan and sample flows.


* Provide input and detailed information towards the global eLims team to set-up the eLims system, including spec, sample plan and sample flows.


* Set-up & maintain the iLabs module including LME module, instrument module and reagent module for the Ghent and Beerse labs.


* Set-up and maintain EMS related eLims master data including schedulers and workitems.


* Support with deviation investigations regarding abnormalities in eLims set-up


* Be a subject matter expert in eLims/iLabs


* Author and update SOPs, WIs and Protocols to support LME, reagent module & instrument module implementations using the Document Management System


* Responsible for providing training & acces in the eLIMS system


* Responsible for user access management of the eLIMS system


* Responsible for User ...