Congenius AG

Senior Expert Container Closure Systems (m/f/d, fix or freelance, 100%)

Your Responsibilities

• Lead the technical development of combination products and medical devices from concept through commercialization
• Define 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 performance
• Provide technical oversight and guidance to external development partners
• Lead complex root cause investigations and resolve device and packaging-related challenges using structured problem-solving methodologies
• Author design control, risk management, verification, and regulatory documentation
• Support regulatory submissions and health authority interactions
• Ensure 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 Experience

• Bachelor'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 atmosphere
• You benefit from flexible working hours and an exciting and versatile field of activity
• You work in a company with a flat hierarchy, short decision-making processes
• You can expect a pleasant working atmosphere, an uncomplicated and collegial cooperation
• You benefit from modern and attractive working conditions and development opportunities
• An attractive salary and very good social benefits round off the offer

Who we are

Congenius 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.