Roche Switzerland bridges the gap between pharmaceuticals and diagnostics. Important research and development functions are located here. For our long-term client, F. Hoffmann-La Roche AG in Basel, we are looking for a

Pre-Fillable Syringe Engineer (m/f/d)

Background:

The Device and Packaging Development Department within Roche Pharma Technical Development is responsible for the development and support of drug delivery devices for the product portfolio. The activities span a range of engineering disciplines from the requirements definition phase, development through to commercialization. Roche is looking for a Pre-Fillable Syringe Engineer to support the development and maintenance of drug delivery devices (e.g. Prefilled Syringes with Needle Safety Devices, Autoinjectors, high-volume Patch-injectors).

Tasks & Responsibilities:

• Serving as primary packaging expert on technical development teams to provide the best-in-class containers and drug delivery devices for our medicines
• Author design control documentation (Design Development Plans, User Requirements Specifications, Design Inputs, Design Outputs, Design Verification Plans and DHF creation/maintenance DHF), conformity assessments and risk management documentation
• Application of theoretical engineering knowledge, to establish robust technical product requirements, and develop engineering design solutions to assure drug containers and devices maintain the required level of performance throughout the life of the product
• Support project leader to successfully bring drug-device combination products and medical devices to the market
• Apply knowledge of the regulatory landscape to ensure standard compliant designs (e.g. ISO 13485, 21CFR820, ISO14971 and 21 CFR 820.30)
• he role will require considerable cross-functional interaction within the department and with partner functions including Device Quality, Device Regulatory, Global Product Strategy, and Pharmaceutical & Analytical Development, as well as with external suppliers

Must Haves:

• University level education (engineering / science degree or related discipline)
• 5+ years proven track record in pharmaceutical, biomedical, material science or different GMP related field
• 5+ years experience within drug delivery device development
• Experience of working in Quality System Regulation (QSR), Design Control or similar working practices
• Sound knowledge of legislation, regulation, industry standards and guidance within the area of combination products and medical devices with experience with Health Authority interactions
• Demonstrable knowledge of the following: drug delivery devices, primary packaging, drug container interactions, parenteral drug delivery
• Demonstrable knowledge of the following: risk assessment, tolerance analysis, statistical techniques, process capability, manufacturing processes and transport studies and validation
• Excellent command of English language

Nice to haves:

• Proficient in German language

Our offer:

• A modern workplace with many social- and green zones
• Fair compensation with 40% home office possibilities
• Familiar motivated team of 14 members
• The ability to work for a company who works towards creating a positive impact on patients livelihood

If you would like an insight into the detailed job description, we look forward to receiving your complete application documents addressed to Ms Nadine Rutz.

Basel City Pharma Vollzeit Fulltime Produktmangement QA Verpackung Ingenieur Verpackungsingenieur