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Compliance Integrator, Senior Engineer

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Job Description


‘Caring for the world, one person at a time ‘… inspires and unites the people of Johnson & Johnson, we embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people.

Janssen Pharmaceutica is part of Johnson & Johnson and is responsible for bringing innovative medicines towards patients throughout the world.

The Clinical Small Molecule Make (CSMM) organisation is part of the Clinical Supply Chain (CSC) and of the Pharmaceutical Development organization and plays a crucial role in delivering medicines to our patients during the development phase of a new product. Within CSMM, the internal and external Pilot Plants are responsible for the upscaling and finetuning of chemical and pharmaceutical processes which result in the successful production of new Active Pharmaceutical Ingredients (API’s) and formulations (DPs). 

Janssen has three state of the art Pilot Plants located in Belgium, the Chemical Development Miniplant (CDMP) and the Pharmaceutical Development Pilot Plant in Beerse, and the Chemical Development Pilot Plant (CDPP) in Geel. Janssen also works with various external partners for the supply of clinical trial material.

 
Description of the Function:

To strengthen our Pilot Plant teams, we are looking for a Senior Engineer to take over the role of Compliance Integrator.

In close collaboration with the pilot plant teams, you are responsible for the Change Control management, starting with organizing the pre-CC meeting, collecting all relevant information and documentation to initiate changes and completing or following up on the completion of the required documentation in TrackWise.

As the subject matter expert (SME) for technical change management, you guide the cross functional project teams through the change control procedure and ensure that equipment qualification in the pilot plants takes place in a GMP compliant, standardized and lean way.

Throughout the change control process, you follow up on open tasks and keep track of the timelines to ensure a timely close out of all technical activities and the change record itself.

In addition, you facilitate the deviation management for our global External Supply Integration (ESI) team by guiding the team through the investigation process, manage all TrackWise related documentation and ensure a timely closure of all deviations and CAPAs.

The major activities in this role are:
  • Initiating technical changes for temporary or permanent equipment adjustments and the implementation of new equipment in our pilot plants.
  • Strict adherence to safety and quality compliance requirements related to these technical changes.
  • Ensuring GMP compliant, standardized and lean equipment qualification.
  • The identification and implementation of standardization and improvement opportunities (safety & environment, quality, cost) with respect to the technical change management process in the pilot plants.
  • Management of deviations and CAPAs for our external partners together with the global ESI team.
  • You are the subject matter expert for technical change management in the pilot plants and act as the point of contact for all parties involved in technical changes, e.g the engineering department, QA, EHS.

Qualifications
  • Master of sciences (chemistry) / industrial engineer / bio-engineer or a comparable level of relevant experience.
  • Experience in Control of Change management in a GMP chemical/pharmaceutical production environment.
  • Experience in a Deviation and CC management system, preferably TrackWise.
  • Safety and quality are your priorities.
  • You have strong communications skills.
  • You have a good sense of urgency and get things done while never compromising on safety and quality.
  • You are a good team player with a strong customer focus, but you can also work independently.
  • You are fluent in Dutch and English in spoken and written language.
  • Project management experience is a plus.
  • A lean certification is a plus.

Primary Location
Belgium-Antwerp-Geel-
Organization
Janssen Pharmaceutica N.V. (7555)
Job Function
Engineering
Requisition ID
1905792253W