Beschreibung
Pre-Filled Syringe (PFS) Engineer (m/w/d) - engineering/German/ English / pharmaceutical / QSRProjekt:
For our customer a big pharmaceutical company in Basel we are looking for a highly qualified Pre-Filled Syringe (PFS) Engineer
Background:
The Device and Packaging Development Department within 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.
We are 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)
Must haves:
* University level education (engineering / science degree or related discipline) and minimum 5 years proven track record in pharmaceutical, biomedical, material science or a related field
* Drug delivery device development with 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
Personal requirements
* 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
Working time:
* 07:00am - 12:00am and 01:00pm - 06:00pm
Reference No.: 919695SGR
Role: Pre-Filled Syringe (PFS) Engineer
Industry: Pharma
Location: Basel
Workload: 100%
Start: 19.10.2020
Duration: 18++
Should you find yourself suitable for this position then please send us your complete CV using the link in this advert. If the position is not a perfect match and you wish to receive other opportunities directly, you can send us your CV anyway via this advert or to jobs[at]itcag[dot]com.
Contact us for further information regarding our company, our positions or our attractive payroll-only-program: .
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 and Life Science 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.