Description
Pre-Filled Syringe (PFS) Engineer in Basel - PharmaBackground:
This contractor role contributes to a team that is responsible for the development of pre-filled syringes of the Roche molecule portfolio in the department for device development.
Role:
- 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 your knowledge of the regulatory landscape to ensure standard compliant designs (e.g. ISO 13485, 21CFR820, ISO14971 and 21 CFR 820.30)
Requirements:
- 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
- University level education (engineering / science degree or related discipline) and minimum 5 year proven track record in pharmaceutical, biomedical, material science or a related field.
- Excellent command of English language and proficiency in German preferable
Nice to have:
- 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: 919102
Industry: Pharma
Location: Region Basel
Start: 01.04.20 +
Duration: 12 Months +
Work Load: 100%
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.