Senior Expert Container Closure Systems (Pre-filled Syringes / Cartridges) (m/f/d, temp or freelance, 100%) in Basel

Senior Expert Container Closure Systems (m/f/d, fix or freelance, 100%)Your ResponsibilitiesLead the technical development of combination products and medical devices from concept through commercializationDefine and assess primary packaging solutions, applying expertise in Type I glass, COP/COC polymers, elastomers, coatings, and extractables & leachables (E&L)Develop container closure and device integration solutions that ensure container integrity, manufacturability, and reliable product performanceProvide technical oversight and guidance to external development partnersLead complex root cause investigations and resolve device and packaging-related challenges using structured problem-solving methodologiesAuthor design control, risk management, verification, and regulatory documentationSupport regulatory submissions and health authority interactionsEnsure compliance with applicable regulations and standards, including ISO 13485, ISO 14971, 21 CFR Part 820, 21 CFR Part 4, ISO 11040, ISO 11608, USP <1207>, USP <381>, and USP <660>Your Skills and ExperienceBachelor's or Master's degree in Engineering or a related technical discipline.5+ years of experience in medical device, combination product, or drug delivery device development within a highly regulated environment (cGxP/QSR).Strong expertise in container closure systems, particularly prefilled syringes and cartridges for parenteral drug delivery.Experience with fill-finish processes, including stoppering technologies.Solid understanding of materials science, elastomers, coatings, defect mechanisms, and performance testing.Proven technical leadership and strong problem-solving capabilities in cross-functional projects.Deep knowledge of the regulatory framework and industry standards governing combination products and medical devices.Experience supporting regulatory submissions, including technical authoring for IND/IMPD and NDA/BLA filings.Proficiency in risk management, reliability engineering, tolerance analysis, statistical methods, and process capability assessments.Excellent communication, documentation, and stakeholder management skills.Fluent in English; German is an advantage.You will work in the Basel area for an international pharmaceutical company in the combination product sector with a very good working atmosphereYou benefit from flexible working hours and an exciting and versatile field of activityYou work in a company with a flat hierarchy, short decision-making processesYou can expect a pleasant working atmosphere, an uncomplicated and collegial cooperationYou benefit from modern and attractive working conditions and development opportunitiesAn attractive salary and very good social benefits round off the offerWho we areCongenius provides tailored expertise and leadership to global firms, established SME`s and aspiring start-ups in the medical device, IVD and pharmaceutical industry. If you enjoy working with a diverse range of people across a broad range of projects and are passionate about making a positive contribution to the MedTech industry, then joining our dynamic team could be your next rewarding career step. #J-18808-Ljbffr