Pre-Filled Syringe Engineer

Pre-Filled Syringe Engineer – Quality System Regulation (QSR), Design Control

Role:
For our client in the Pharma industry based in Basel we are looking for a Pre-Filled Syringe Engineer.

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 through to commercialization and marketed product support.
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).

Areas of responsibility:
* 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 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)

Professional and technical requirements:
* 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 (cGxP),
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 command of English language and proficiency in German preferable
* 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.

Reference no: 921245 AD
Role: Basel
Industry: Pharmaceutical industry
Workload: 100%
Location: Basel, Switzerland
Start date: asap
Duration: 12 months contract, with possible extension

About us:
ITech Consult is a certified ISO 9001:2015 Swiss company with offices also located in Germany and
Ireland. ITech Consult is specialised in delivering IT candidates for contract work. We were founded in
1997 by IT professionals; hence we well understand what it means to be professionally supported in your
search for a new project and being employed.