ppJoin a global leader in the pharmaceutical industry as a bDesign Control Engineer /b within the bCombination Products Development /b team, and play a pivotal role in bdesign control, risk management, technical documentation, and cross-functional collaboration /b with RD, Quality, Technical Operations, and Manufacturing teams. This role focuses on the bdevelopment, optimization, and lifecycle management /b of cutting-edge bdrug-device combination products /b for brespiratory, subcutaneous, and intravenous drug delivery /b. /ph3Key Responsibilities /h3ulliDevelop and maintain bDesign Control documentation /b throughout the product lifecycle. /liliAuthor and manage bRisk Management documentation /b in compliance with bISO 14971 /b. /liliSupport the bdevelopment, customization, qualification, and optimization /b of drug delivery systems and combination products. /liliContribute to bDesign Verification and Validation /b activities. /liliParticipate in bDesign Reviews /b and technical assessments. /liliAssist in btechnology transfer and industrialization /b activities. /liliPrepare btechnical documentation /b for quality and regulatory submissions. /liliCollaborate with bRD, Quality, Regulatory Affairs, Technical Operations, and external partners /b. /liliEnsure compliance with bregulatory requirements and industry standards /b. /liliStay updated on bindustry trends, regulations, and best practices /b in Combination Products and Drug Delivery Systems. /li /ulh3Required Qualifications /h3ulliMaster’s degree or PhD in bBiomedical Engineering, Mechanical Engineering, Electrical Engineering, or a related scientific discipline /b. /liliMinimum 5 years in bCombination Products, Drug Delivery Systems, Medical Device Development, or Pharmaceutical/Biotechnology environments /b. /liliStrong background in bDesign Control, Risk Management, Product Development, Technical Documentation, and Verification Validation /b. /liliExperience working in bregulated environments /b. /li /ulpHands-on experience with the following are highly appreciated: /pullibAutoinjectors, Pen Injectors, Prefilled Syringes, Safety Syringes, Inhalation Devices, or Drug Delivery Platforms /b. /lilibHuman Factors Engineering /b or bUsability Engineering /b. /lilibISO 14971, ISO 13485, FDA Design Controls, MDR, or Combination Product regulations /b. /li /ul /p #J-18808-Ljbffr
Design Control Engineer – Combination Products & Drug Delivery Systems Arbeitgeber: Alten
ALTEN ist ein hervorragender Arbeitgeber, der dir als Werkstudent im Projektmanagement am Standort Berlin die Möglichkeit bietet, praktische Erfahrungen in einem dynamischen Umfeld zu sammeln. Unsere offene und inklusive Unternehmenskultur fördert die persönliche und berufliche Entwicklung, während du an innovativen Projekten in der Luftfahrtbranche mitarbeitest. Zudem profitierst du von flexiblen Arbeitszeiten und der Chance, mit internationalen Teams zusammenzuarbeiten, was deine Karrierechancen erheblich steigert.
