­vanced Process Engineer (SME)

Janssen Pharmaceutica NV is recruiting for an Advanced Process Engineer, located preferably in Beerse (Belgium), Leiden (The Netherlands), Titusville (New Jersey), Cork (Ireland), Latina (Italy). The Advanced Process Engineer envisions how the process SME operates in 2040 driving robustness and reliability of our manufacturing processes through near real-time accessibility to excipient, process and finished product data for in-depth advanced data analysis, strong capability of aggregation and contextualization of data, closed-loop real-time process monitoring and control and real-time release testing approaches. The Advanced Process Engineer translates this vision into capabilities in the domain of data extraction, aggregation and contextualization as well as harmonization of those capabilities across the JSC network. The Advanced Process Engineer actively collaborates with partner functions via long-term strategic programs and short-term targeted project plans towards the detailed deployment of the above-mentioned capabilities. Key Responsibilities: Actively and iteratively collaborate with major TO functions in New Product Introduction, Life Cycle Management and Technology & Innovation with the objective to thoroughly understand today’s job as well as future job and to clearly assemble the fundamental changes these jobs will undergo in the next decade Systematically and iteratively translate future job requirements such as swift execution of process investigations, lean and thoughtful tech transfer, introduction of closed-loop real-time process control and real-time release testing approaches into desired digital capabilities in the domain of data extraction, data aggregation and data contextualization as well as the harmonization of systems supporting those digital capabilities Actively discuss the desired TO digital capabilities with supporting IT functions and build consensus on a long-term digital capability vision Actively collaborate with supporting IT functions to translate the long-term digital capability vision into a multi-generational implementation program Drive and handle projects which are initiated in the context of the multi-generational program and which seek at building a fraction of the desired TO digital capabilities Ensure through the execution of multi-generational program projects the establishment of data extraction, aggregation and contextualization capabilities which directly and effectively support future TO job requirements Qualifications Qualifications Education: Master in Chemical Engineering, Pharmaceutical Sciences, Electro-Mechanical Engineering, Electronics, Computing Sciences or equivalent. Any specialization in data science, statistics and/or modeling is helpful. Experience and Skills: Required: Proven track record in developing, transferring, managing and supervising pharmaceutical and/or biotechnology manufacturing processes Profound knowledge regarding manufacturing process performance and its measurement, process failure and root cause analysis, continuous improvement Deep knowledge regarding manufacturing source systems, historians, laboratory information management systems, local and cloud-based data warehouses & data lakes and their inter-connectivity Substantial expertise regarding master data design and various (system-specific) methodologies to provide process-specific context to data Extended expertise regarding Project Management and Execution approaches Hands-on expertise regarding data analytics, statistics and modeling Knowledge of Quality-by-Design principles and concepts Preferred: Knowledge regarding the development, testing and introduction of data extraction and data analysis applications Expertise regarding data integrity and data security Strong insight into analytical method development, transfer and validation for release and stability testing purposes and the impact of method performance on the evaluation of test results Knowledge regarding basic quality & compliance and GMP requirements and guidelines Basic understanding about regulatory filing requirements, dossier submission and approval processes Other: Excellent oral and written communication skills, proficiency in English both verbal and in writing and well-developed intercultural social skills are required; additional language skills are an advantage Proficiency in planning, proactivity, self-motivation, and the ability to work independently are required Excellent leadership skills with the ability to operate optimally in a dynamic work environment and collaborate with multi-functional teams Deep knowledge of continuous improvement tools, lean manufacturing and six-sigma is preferred; Six Sigma black belt certification is a plus Ability to make timely decisions and operate efficiently in times of ambiguity Demonstrated knowledge and expertise in bridging technical and business fields, evaluating and resolving risks is required Being meticulous, highly organized and able to run multiple tasks, handle timelines and deliver quality job is required Requires up to 35% domestic and international travel Primary Location Belgium-Antwerp-Beerse- Other Locations Europe/Middle East/Africa-Netherlands-South Holland-Leiden, Europe/Middle East/Africa-Ireland-Cork-Cork, Europe/Middle East/Africa-Italy-Latina, North America-United States-Florida-Titusville Organization Janssen Pharmaceutica N.V. (7555) Job Function Engineering Requisition ID 2206046973W