Senior Engineer Manufacturing Sciences & Technology

Contenido de trabajo

Janssen Pharmaceutica NV is recruiting for a Senior Engineer Manufacturing Sciences & Technology – Pharmaceutical Product Development & Supply located in Beerse, Belgium. The MST Engineer is responsible for successful introduction and follow-up of clinical manufacturing activities in the Drug Product (DP)-Pilot Plant (PP), being the PP-representative in the drug product development teams. The scientist/engineer supports process development, plant introduction, scale-up & tech-transfer of DP processes from DPDS to JSC from a (clinical) manufacturing perspective. The MST Engineer is also technology owner of technologies within the DP PP. Qualifications Key Responsibilities: Pilot plant representative in the Drug Product Development and Clinical Supply Chain project teams, ensuring E2E risk management in support of robust process development and successful clinical manufacturing. Accountable for successful introduction of clinical manufacturing activities in the Pilot Plant, acting as a receiving partner for the DP development team Follow up on the progress of the project together with the Drug Product Development organisation to assure timely readiness of installation at receiving site. Start from the detailed knowledge of the equipment and the processes during development to deliver DPDS design inputs for the receiving commercial site (URS and process requirements) Establish manufacturing sciences expertise for different equipment platforms, in a multi-functional collaboration with DPD and PAT-experts. This includes the development and implementation of new technologies/processes/PAT applications Act as Technology Owner, covering multiple equipment platforms Activities include: Provide manufacturing sciences expertise to the Drug Product Development teams. Tech Transfer support: commercial plant readiness for registration, launch and commercial production, incl. DoE & Scale-up support. Concept, Design, Installation and Implementation of new equipment and PAT applications Support optimizations and / or changes to existing equipment to improve Pilot Plants’ capability and/or capacity. Qualifications Education: Preferably (bio)chemical or mechanical engineering degree or equivalent with at least 2 years of experience in pharmaceutical development/engineering area. Experience and Skills: Preferred: Knowledge of oral solid dosage, liquid and/or parenteral products, processes and technologies: conventional technologies as well as innovative technologies like spray drying, extrusion, nanomilling, continuous manufacturing, PAT… Knowledge on risk management Broad technical background (electrical, pneumatic, mechanics, HVAC,…) Basic knowledge of qualification, validation and change management systems in the pharmaceutical industry is a plus. Able to work in highly regulated environment (FDA/J&J standards and guidelines, general GMP guidelines) Builds or possesses an excellent internal and external network of manufacturing sciences, engineering and development specialists Project management skills Excellent communication skills in a global environment Other: Excellent knowledge of English. Willing to learn Dutch Willing to travel (up to 30%) About Janssen, the Pharmaceutical Companies of Johnson & Johnson At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly based healthcare company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. At Janssen, we’re creating a future where disease is a thing of the past. We are working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension. We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status. Ready to be part of something great? Don’t forget to apply. We want YOU! Primary Location Belgium-Antwerp-Beerse- Organization Janssen Pharmaceutica N.V. (7555) Job Function R&D Requisition ID 2206002005W