Pre-Filled Syringe (PFS) Engineer (m/f/d)

REFERENCE NUMBER:

507037/1

MY DUTIES:

- 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
- Serving as primary packaging expert on technical development teams to provide the best-in-class containers and drug delivery devices for our medicines
- 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 (assuring safety for patients and users such as doctors or nurses)
- Apply knowledge of the regulatory landscape to ensure standard compliant packaging designs (e.g. ISO 13485, 21CFR820, ISO14971 and 21 CFR 820.30) 

MY QUALIFICATIONS:

- Excellent documentation, presentation and interpersonal communication skills with fluent language skills in English (German speaking/writing skills are beneficial)
- 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
- University level education (engineering / science degree or related discipline) and proven track record in pharmaceutical, biomedical, material science or a related field
- 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, process capability, manufacturing processes and transport studies

MY BENEFITS:

- Central location of the work place within a diverse and interdisciplinar environment
- Individual all-round care: Support throughout the entire application phase as well as project phase

ABOUT HAYS:

Our many years of recruitment experience and specialist knowledge of the engineering job market make us a strong partner for engineers and technicians. We maintain intensive relationships with customers across all industries and so can provide engineering specialists with exciting projects and attractive job opportunities. Whether it's working with an international automotive manufacturer or a regional market leader in mechanical engineering, drawing on your interests and experience, we will find the right job to suit you. Because with us, specialists find their ideal working environment – all completely free of charge. Register with us and reap the benefits of job offers that are both interesting and relevant to your skills and experience.

MY CONTACT AT HAYS:

My contact person
Achim Barth

Reference number
507037/1

Contact
E-Mail: [email protected]