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.
Your Responsibilities
* Evaluate and develop new materials and/or alternate packaging materials, secondary packaging solutions, or packaging systems based on product, regulatory, business, or technical requirements for combination products.
* Communicate key risks/challenges to stakeholders as necessary
* Author technical documentation to support packaging development organization (e.g., requirements documents, risk assessments, protocols/reports)
* Integrate industrialization requirements for high-volume products into packaging development
* Support packaging verification activities (qualification project plan, qualification protocols, qualification reports, and qualification summary reports)
* Advise and consult customers and suppliers (take indirect leadership as appropriate)
* Interact with suppliers and CMOs; willingness to travel up to 10% nationally and internationally
Your Skills and Experience
* Master of Science (MSc), preferably with an engineering degree in packaging, materials science, or a related field
* Professional background: 5+ years of experience in medical device regulation and package engineering within the pharma or medical device industry
* Experience in project management in the pharma industry
* Strong experience in budget planning, project timeline planning, and problem solving
* Knowledge of ISO 13485
* Knowledge of ASTM D4169, ASTM D7386, and container closure integrity testing
* Hands on working experience in GMP environment and authoring technical documents
* Confident in presenting, networking, and building relationships
* Team player who works efficiently and flexibly within interdisciplinary teams
* Decision maker, taking the lead where appropriate and necessary
* Fluent in English - written and spoken, German is a nice to have
* You will work in the Berne area for an ambitious, dynamic small company in the medical technology sector
* 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
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