Job Detail

For our client, a worldwide leading Swiss pharmaceutical company in Basel. We are looking for a motivated and flexible Pre-Filled Syringe (PFS) Engineer for a one year contract (temp).

Backround
The Device and Packaging Development Department 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 through to commercialization and marketed product support. The client 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).

Tasks

• 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)

Must haves

• University level education (engineering / science degree or related discipline)


• At least 5 years proven track record in pharmaceutical, biomedical, material science or a related field


• At least 5 years experience within drug delivery device development, experience of working in pharma or other closely-regulated environment, under current Good Practice (GxP), 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, risk assessment, tolerance analysis, statistical techniques, process capability, manufacturing processes and transport studies and validation


• Excellent documentation, presentation and interpersonal communication skills


• 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


• Excellent command of English language and proficiency in German preferable

Are you interested? Do not hesitate and submit your complete application documents online today.

We value diversity and therefore welcome all applications - regardless of gender, social origin, religion/belief, age or identity.

We also process applications by post, but will not return them for administrative reasons.