For our client, a leading international pharmaceutical company with headquarters in Basel, we are looking or a motivated personality in the function of
Pre-Fillable Syringe Engineer
- 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)
- 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)
- Sound knowledge of legislation, regulation, industry standards and guidance within the area of combination products and medical devices with experience with Health Authority interactions
- 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
Place of work: Basel (Normally onsite but currently home office)
Duration: 1 year
Please apply online. For further information about the position, please contact: Mrs Diana Steinhauer (+41 61 270 80 16).