22 jobs voor clinical support engineer gevonden

Position: Change Management, Communications & Engagement Support Intern

Goal of assignment:

DATA4YOU is a multi-year (2021 - 2025) strategic program delivering the state-of-the-art J&J clinical

data review platform leveraging AI and ML to facilitate the work of key personas managing clinical trials.

This program comes with a high investment and a high expectation toward cost & time savings,

operational and organizational benefits.

One of the pillars in the DATA4YOU program is investing in Organizational Change Management and

Communications as the user community is very diverse.For this work stream we are looking for

additional support to set the team up for success.

Change Management, Communications & Engagement Support Intern role specific responsibilities:

We are looking for someone who will be joining the Program Change Management &Communications

team.This person will be given several deliverables to coordinate and

help deliver within the set project timelines.Examples of assignments:

- Building communications materials such as presentations that are visually appealing

- Building creative supportive materials such as e-flyers, posters, animated banners supporting

announcements

- Organize small events

GMP cleanroom environment.Job duties are performed within a team according to an assigned, production shift schedule.Reviews documentation for all manufacturing activity execution in accordance with good documentation practices.Independently executes paper/electronic batch record review associated with commercial; development; and engineering production.Performs duties under limited supervision and according to standard operating and manufacturing procedures.Contributes to process improvement of batch records and turnaround times to ensure turnaround times and QA batch disposition deadlines.Collaborates within Manufacturing to resolve batch record discrepancies or errors as it relates to Good Documentation Practices or Manufacturing Execution System (MES) inventory.Implements appropriate corrective and preventive actions by investigating non conformances in a timely manner.Strive to reduce non conformances in supported areas by dedicatedly driving compliance.Perform tasks in a manner consistent with the safety policies; quality systems and c.

.Design, develop, and execute automated test scripts for database systems using industry standard tools and frameworks .

Managing daily production planning and routine production flow..Supporting manufacturing investigations and creating/revising operational procedures, including work instructions and batch records..

GMP cleanroom.You will oversee various units within process operations, including component preparation, manufacturing support, fill & finish, and cryopreservation, ensuring compliance with c.

You continuously improve the software team processes to ensure they cover the relevant functional safety standards..You work autonomously with support of your team lead..

.Lead and supervise various units within the process, such as component preparation, production support activities, process, filling & finishing, and cryopreservation..

The Program

The Johnson & Johnson Supply Chain Internship offers you the opportunity to get a first glimpse of

your potential future career and to apply your academic knowledge in a real-life supply chain context.

Our internship is a great way to get noticed within the world of J&J!

As an intern you will be part of a team and get to experience the daily challenges we face in the Johnson

& Johnson Supply Chain.The intern will be assigned to any of the following business areas:

- Advanced Therapies (Beerse or Gent)

Project examples: Optimize logistics flows, support operational readiness of new CAR-T EMEA

production sites, etc.

- Deliver Distribution & Warehousing (Beerse, Diegem or Courcelles)

Project examples: Support development of CO2/Sustainability calculation in order frequency

and transportation, Develop site strategic roadmap, Inbound/Outbound process

improvements, etc.

- Innovative Medicine Supply Chain.Chemical Production (Geel)

Project examples: Digitization projects, Research on equivalency of different reactors and on

performance of materials towards the chemical processes, Data analytics for process

optimization, etc.

- Innovative Medicine Supply Chain.Pharmaceutical Production (Beerse)

Project examples: Conduct Root Cause Problem Solving, Initiate business cases and

Implement process improvement actions, including Kaizen.

- Clinical Supply Chain (Beerse)

Project examples: Data analytics for process optimization, Sustainability & Innovation

projects, Support implementation of new production infrastructure etc.

Lead and supervise various units within the process, such as component preparation, production support activities, process, filling & finishing, and cryopreservation..Build strong collaborative relationships with various departments, including Manufacturing Operations, QC IPC Operations, Quality, Facilities & Engineering, MS&T/Manufacturing Excellence, Training, Planning, Procurement & Supply Chain/Warehouse..

TheDPR team operates across a portfolio of projects at the interface of the discovery anddevelopment space, from lead identification through the selection of drug candidates.Thegroup facilitates medicinal chemistry research by finding solutions to synthetic bottlenecks,enabling access to novel chemical space, and translating chemistry innovations to thedevelopment of efficient routes for the synthesis of small molecule drug candidates advancinginto development.The API Development chemistry team (DC) team generates creative and innovative waystowards new synthetic routes and solutions that enable large scale manufacturing of targetActive Pharmaceutical Ingredients.

.Establish key stakeholder relationships with internal stakeholders (Manufacturing Operations, QC IPC Operations, Quality, Facilities & Engineering, MS&T/Manufacturing Excellence, Planning).

Component preparation manufacturing, manufacturing support operations, process, fill & finish and cryopreservation) according to standard operating procedures and batch records and ensure safe and compliant manufacturing operations according to c.GMP requirements..

Capsule filling machine), but also globally used web applications, Clinical Trial Management Systems, complex Manufacturing Execution Systems, SAP systems, medical devices, etc… 

Component preparation manufacturing, manufacturing support operations, process, fill & finish and cryopreservation) according to standard operating procedures and batch records and ensure safe and compliant manufacturing operations according to c.GMP requirements..

Component preparation manufacturing, manufacturing support operations, CAR T process, fill & finish and cryopreservation) according to standard operating procedures and batch records and ensure safe and compliant manufacturing operations according to requirements.You will work in a team based, cross functional environment to complete production tasks required per schedule and drive continuous improvement of manufacturing operations leveraging own observation as well as input of junior team members.

Provides support to writing and revising SOPs and associated documents (incl.batch records, work files, checklists, procedures) related to routine Production documentation..

Batch records, work files, checklists, procedures) related to routine Production documentation..Manages raw materials, consumables and wastes, incl.

Equipment Maintenance: Keep equipment running smoothly by following instructions, troubleshooting issues, and coordinating repairs..Process Optimization: Contribute to process optimization, introduce new products, procedures, and equipment in GMP areas..

Equipment Maintenance: Keep equipment running smoothly by following instructions, troubleshooting issues, and coordinating repairs..Process Optimization: Contribute to process optimization, introduce new products, procedures, and equipment in GMP areas..

Equipment Maintenance: Keep equipment running smoothly by following instructions, troubleshooting issues, and coordinating repairs..Process Optimization: Contribute to process optimization, introduce new products, procedures and equipment in GMP areas..

Provides support to writing and revising SOPs and associated documents (incl.batch records, work files, checklists, procedures) related to routine Production documentation..

Cleanroom Manufacturing: Operate daily in a Grade A/B/C/D cleanroom environment, maintaining equipment and facility cleanliness..Aseptic Processing: Manufacture clinical and commercial grade ATMPs through aseptic manual processes, including cell isolation, selection, activation, transduction, culture, fill and finish, and cryopreservation..