Engineer in Drug delivery device development

We make it GmbH is a national company operating in Switzerland which thanks to many years of successful experience has a high level of expertise in the personnel services sector. Concentration of brokerage activities on the core areas of industry technology office/administration engineering pharmaceuticals and IT. We make it
GmbH places the highest demands on quality ethics and discretion.

For our customer the company F. Hoffmann La Roche based in Basel we are looking for a PreFillable 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 recruiting for a PreFillable Syringe Engineer to support the development and maintenance of drug delivery devices (e.g. Prefilled Syringes with Needle Safety Devices Autoinjectors highvolume Patchinjectors).

The perfect candidate has minimum 5 years experience in drug delivery device development pref. prefilled 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

• Serving as primary packaging expert on technical development teams to provide the bestinclass 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 drugdevice combination products and medical devices to the market
• Apply knowledge of the regulatory landscape to ensure standard compliant designs (e.g. ISOCFR820 ISO14971 and 21 CFR 820.30)
• The role will require considerable crossfunctional 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

Requirements

• 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

Work hours

• Standard 40 h/ Week
• Remote/Home Office: max. 40%

Are you interested

Then Ms. Emina Becic would be pleased to receive youre application documents (CV Work reference letters and diplomas).

We look forward to hearing from you.