Pre-Fillable Syringe Engineer

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

Pre-Fillable Syringe Engineer (f/m/d) - ISO13485 / QSR /German / Validation / GMP

Project:
For our customer a big pharmaceutical company in Basel we are looking for a highly qualified Pre-Fillable Syringe Engineer

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 recruiting 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).

The perfect candidate has minimum 5 years' experience in drug delivery device development, pref. pre-filled syringes, in a GMP regulated environment. Experience with Quality System Regulation (QSR), Design Control or similar working practices is required and the person needs to have a sound knowledge of legislation, regulation, industry standards and guidance within the area of combination products and medical devices.

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)
• The 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)

• At least 5 years proven track record in pharmaceutical, biomedical, material science or different GMP related field
• At least 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 and proficiency in German preferable
• Excellent documentation, presentation and interpersonal communication skills

Reference Nr.: 923193SGR
Role: Pre-Fillable Syringe Engineer
Industry: Pharma
Workplace: Basel
Pensum: 100%
Start: 01.03.2024
Duration: unlimited

Deadline : 02.02.2024