Cleaning Science Engineer
Role details
Job location
Tech stack
Job description
Johnson & Johnson Innovative Medicine Supply Chain, Manufacturing Science and Technology (MSAT) Geel is recruiting a Cleaning Science Engineer. This role is focusing on the cleaning processes in our small molecule drug substance Geel site and is located in Geel, Belgium. Janssen Geel is the largest internal chemical manufacturing site of Active pharmaceutical ingredients (API) and spray dried powders (SDP) in the internal Johnson & Johnson network
The cleaning science engineer supports our cleaning processes. Performing robust cleaning processes according to the latest standards, introducing process optimizations, supporting new product and technology introductions, supporting issue management from a science perspective and overall performance management are key objectives in this role.
This position strongly contributes to the global Small Molecule Drug Substance (SM DS) MSAT strategy and the productivity performance of the Geel site. The Cleaning science engineer is a team member of the Geel site MSAT team and is expected to have a strong cross functional collaboration mindset.
The key responsibilities are as follows:
- Own cleaning processes to meet Safety, quality, environmental and cost standards
- Life cycle management of cleaning processes for execution in production systems (MES, SAP (future Transcend))
- SPOC to the business owners, QA, during audits for cleaning recipes, protocols and reports, but also leading root cause problem solving for cleaning process related issues
- Support of the Cleaning Science Lab for rapid investigational support and continued process improvements
- Use innovation and PAT technologies for continuous improvement of cleaning processes
- support the CIP/Cost avoidance targets focusing on cleaning processes
- Maintain Gantts of cleaning processes
- Assess CCs/define actions for process/equipment changes
- Support equipment specific studies as input for cleaning validation, e.g. Impact assessment cleaning (FMEA), Equivalency studies cleaning, Cleaning boundary studies.
- Review cleaning VMP / protocols / reports / trend reports / cleaning quality reviews delivered by validation team
- Closely collaborate with the site-based validation team, the global cleaning community of practice and site-based stakeholders (Operations, QA, Planning, MAM, Development…)
- Reviewing of Cleaning Quality Reviews (CQR)
- Support equipment specific studies as input for cleaning validation, e.g. Impact assessment cleaning (FMEA), Equivalency studies cleaning, Cleaning boundary studies.
Requirements
Do you have experience in Project management?, Do you have a Master's degree?, * Master's Degree or PhD preferably in Chemical engineering or process technology (bioengineering, industrial engineering or chemistry), or proven record in an industrial, operational environment.
- Solid understanding of API manufacturing.
- Affinity and pronounced interest with data analytical tools and proven understanding in chemical synthesis.
- Ability to lead and encourage teams, strong interpersonal skills, e.g. influencing and handling conflicting interests.
- Able to take decisions autonomously. Strong skills in communication and a result driven personality.
- Strong analytical skills, high level of accuracy, good acumen on cost improvements.
- Owns good project management, organizing, planning and coordination skills. Experience in process excellence, lean production concepts and tools (certification is a plus).
- Develops strong collaborations with internal and external business partners.
- Big picture orientation with attention to detail - able to operate in two 'worlds' at one time, sees the why as well as the what; can zoom in or out as needed.
- Working knowledge of English (both verbally and written) and Dutch (or willing to develop proficiency in Dutch)
