Mandated by one of our clients, we are looking for a:
- Support design transfer projects for portfolio products within the agreed timelines and quality requirements.
- Author scientific reports, memos, and rationales related to design transfer, risk management, and control strategy documentation.
- Plan, design, execute and document testing within the framework of process design and combination product verification activities
- Collaborate effectively with broad cross-functional internal and external teams in developing strategies and concepts for the manufacturing of medical devices and combination products.
- Ensure the qualification and validation of processes and equipment in collaboration with internal V&V specialists.
- Apply your knowledge of the regulatory landscape to ensure standard-compliant designs (e.g. ISO 13485, 21CFR820, ISO14971 and 21 CFR 820.30).
• Min. Bachelor degree in engineering or related discipline
• Min. 2-5 years of experience in product commercialization or process engineering /industrialization, preferred in the pharmaceutical industry
• Hands-on knowledge on product industrialization using semi- or fully-automated assembly and packaging processes
• Broad experience on manufacturing technologies for low and high-volume applications (e.g. assembly, packaging, injection molding, machining, marking, printing, gluing, sealing, welding)
• Technical/ Digital Flair
• German and English fluent needed
• Person that can learn quickly and is keen to broaden his or hers knowledge
• Enthusiastic team player
• Communication skills
Nice to Haves:
• Experience with ISO 13485, 21CFR820, ISO14971 and 21 CFR 820.30 regulations is a plus
• Experience in an equipment supplier for a pharmaceutical company or CMO // Medical Device environment
• Experience in working in a project environment, preferred experience in project management
• Experience of working in pharma or other closely-regulated environments is preferred
We look forward to receiving your application via the online application form.