Process and Project Engineer Clinical Supply Chain API SM Job

Job description

Process and Project Engineer Clinical Supply Chain API SM-000010RLDescriptionBusiness DescriptionThe Clinical Supply Chain (CSC) department is part of the Pharmaceutical Development organization within Janssen.
The goal of the Clinical Supply Chain group is to become an industry leading clinical supply chain reliably delivering medicines to our patients with best in class speed & flexibility, resulting in highest end-to-end productivity. Within the CSC, the API (Active Pharmaceutical Ingredients) organization is responsible for :
- Supply of small molecules API’s needed for clinical studies. These API’s are produced in the Chemical Development Miniplant in Beerse in a day-shift regime and in the Chemical Development Pilot Plant in Geel in a full continuous shift regime. Part of the portfolio is also produced at external partners, mainly in China.
- Production and launch of low volume commercial products.
- Providing facilities, equipment and process expertise to ensure pilot and commercial processes are successfully transferred, scaled up and executed.
Description of the Role:For the Chemical Development Miniplant (CDMP) in Beerse we are looking for a process and project engineer
- After an extensive training in the CDMP you will become plantexpert covering both process equipment and the process control system. In this role you are responsible for:
- Representing the CDMP for new product introductions from API-Development, in close cooperation with the Scientific Integrator and the CDMP –team. All plant related aspects of this transfer are covered by the candidate: process-safety, product-quality, technical modifications, training ...
- Support the production activities in the plant taking into account all compliance related requirements (EHS and Quality)
- Lead optimization activities related to current and new chemical processes, making use of PAT-tools in combination with data-analysis and experience which is build-up during batch-execution.
- You support operational activities in the CDMP: Management of change, deviation handling and investigations, continuous improvement programs. You make use of LEAN techniques and root cause analysis.
- You support the execution of the CDMP technical masterplan . The purpose of this masterplan is to secure a reliable and flexible supply taking into account the future technology needs.
Qualifications
- A degree (MS/PhD) in chemical engineering or with chemical pharmaceutical operations/development experience.
- The candidate must have an outspoken interest in technology and for working in a chemical operational development environment . This means short timelines, high flexibility in combination with high accuracy.
- Basic understanding of chemical process safety requirements and c-GMP requirements is preferred
- Good organizational skills, capable of managing multiple projects is a requirement. Working knowledge of project management principles is an advantage.
- Successful candidate must be able to demonstrate strong cross-functional collaboration, good communication and teaming skills.
What’s in it for you…?“Caring for the world, one person at a time…”As an employee we consider you as our most valuable asset. We take your career seriously.
As part of a global team in an innovative environment your development is key and our day-to-day responsibility.
Through e-university, on the job training, various projects and programs, we ensure your personal growth.
Our benefits make sure we care for you and your family now and in the future.
Primary Location:Europe/Middle East/Africa-Belgium-Antwerp-BeerseOrganization: Janssen Pharmaceutica N.V. (7555)Job Function: Process Engineering