Beschreibung
Pre-Fillable Syringe Engineer (f/m/d) - GMP / drug delivery device development / Quality System Regulation (QSR / Design Control / Primary Packaging / Manufacturing Processes / statistical techniques / English & GermanProject:
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.: 923193SDA
Role: Pre-Fillable Syringe Engineer
Industrie: Pharma
Workplace: Basel
Pensum: 100% (Max 2 days Home office per week)
Start : ASAP (latest start date: 01.06.2024)
Duration: unlimited
Deadline: 17.03.2024
If you are interested in this position, please send us your complete dossier via the link in this advertisement. If this position does not fit your profile and you wish to be considered for another position directly, you can also send us your dossier via this ad or to jobs[at]itcag[dot]com.
Contact us for more information about our company, our positions or our attractive Payroll-Only programme: .
About us:
ITech Consult is an ISO 9001:2015 certified Swiss company with offices in Germany and Ireland. ITech Consult specialises in the placement of highly qualified candidates for recruitment in the fields of IT, Life Science & Engineering.
We offer staff leasing & payroll services. For our candidates this is free of charge, also for Payroll we do not charge you any additional fees.