Scientific Principal Engineer

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: R&D Product Development Job Sub Function: R&D Process Engineering Job Category: Scientific/Technology All Job Posting Locations: Beerse, Antwerp, Belgium Job Description: Position: Principal Engineer – Manufacturing Sciences and Technology, Global Product Integration At Johnson & Johnson, we’re on a mission to improve the lives of millions of patients around the globe. If you’re ready to be a pioneer in the development of innovative therapeutics, we want you to join us on this exciting journey! This role offers a unique opportunity for a dynamic Manufacturing Sciences & Technology Engineer to make a real impact. About the Department Drug Product Research & Development (DPRD) is part 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 this organisation, the Pharmaceutical Supply & Engineering Sciences team (PSES) is responsible for the upscaling and fine tuning of formulation and processes which result in the successful clinical manufacturing of new Drug Product (DP). Our activities include all in-house and outsourced planning, manufacturing and distribution of clinical supplies through a global network. We supply more than 60.000 patients in more than 300 clinical trials every year. For our DP Pilot plant in Beerse, Antwerp, Belgium we are looking for a Principal Engineer, global product integration in the MST team. You will be accountable for the management of clinical manufacturing activities for synthetic-molecule drug products from the internal Drug Product Pilot Plant (DP-Pilot Plant) and the external CMO network. This role covers processes for oral solids, liquids, and parenteral applications, across small-scale and pilot-scale operations and the use of innovative pilot-plant manufacturing platforms. Your role As a Manufacturing Sciences & Technology (MST) Principal Engineer you will be a core member of the Pharmaceutical Supply and Engineering Sciences organization. The MST engineer is responsible for successful introduction and follow-up of clinical manufacturing activities in the Drug Product (DP)-Pilot Plant (PP) and across the external network, being the PSES representative in the drug product development team and clinical supply chain team. Working within an international setting and in cross functional teams, the MST engineer is responsible for and supports: Lean and right first-time process introduction in the internal pilot plant, Pilot-plant / CMO manufacturing readiness, Potential scale-up & tech-transfer preparation of drug product processes from the PP to commercial manufacturing facilities from a (clinical) manufacturing perspective. Account ownership of 1 or more external CMO’s Technologies span over processes for oral solids, liquids and parenteral applications, ranging from small scale to pilot-scale processes e.g. from a single punch tablet press to a continuous manufacturing line and e.g. vial filling for parenteral production. As a key player of our PSES team, you will help shape the future of drug product formulation and process development. Your responsibilities will include: Dynamic Project Leadership and Coordination · Act as PSES representative in Drug Product Development and Clinical Supply Chain project teams, assuring and coordinating DP clinical readiness activities. · Serve as the primary internal point of contact within development and pilot-plant operations and team members, fostering collaborative relationships to internalize new manufacturing processes that ensure right-first-time outcomes while optimizing workflows. · Proactively identify, lead, and navigate project critical path milestones, adeptly managing risks and implementing innovative corrective actions to sustain robust process development and successful clinical manufacturing. · Taking ownership of dedicated project budget to fulfill financial commitments. Transformative Process Improvement and Optimization · Drive the evolution of existing workflows by addressing challenges head-on and uncovering opportunities to enhance early development pilot-plant tech transfers, manufacturing, and business processes within an international team and on a global scale. · Establish, review, and endorse manufacturing instructions and specifications, collaborating effectively with internal departments and pilot-plant teams. Innovation-Focused Expertise - Development and Collaboration for Success · Cultivate manufacturing sciences expertise across diverse manufacturing platforms through cross-functional collaboration with development teams and subject matter experts, ensuring alignment with latest industry standards. · Take ownership of the successful introduction of clinical manufacturing activities in the internal pilot plant, acting as a key collaborator and partner for the DP development team, contributing to advancements in pharmaceutical manufacturing and assuring right-first-time manufacturing of clinical drug product material. Your Qualifications MSc or PhD in chemistry, pharmaceutical sciences, (bio)chemical or mechanical engineering, or other discipline within pharmaceutical/biotechnology sciences with at least 10 years experience in GMP regulated pharmaceutical development/engineering area. Familiarity with oral solid dosage, liquid, and/or parenteral product manufacturing, as well as conventional and some innovative manufacturing technologies like spray drying, extrusion, and continuous manufacturing. Basic understanding of process analytical technologies is desirable. Experience working in regulated environments (e.g., FDA standards and general GMP guidelines) is important. Awareness of relevant internal and external regulations regarding equipment requirements and processes through literature, workshops, and training is beneficial. Good organizational and coordination skills, with knowledge of risk management. Able to search literature and utilize other resources effe