Global Technical Development (PTD) is an organization of over two thousand people globally that are integral for the mission of Roche to develop meaningful medicines for patients. Therefore, we actively collaborate and develop creative technical solutions to bridge early-stage, late-stage and commercial product needs. The mandate of the group is, to expertly deliver the pipeline and supply quality products to patients. The group excels in its work through innovation, teamwork, dedication, and mutual respect and contributes every single day, continuously improving what it does.
Pharma Technical Development Europe Biologics brings game-changing therapies from clinical phase I into the market to serve every patient, every day. Our core business is to develop safe, innovative and effective drugs using cutting edge technologies for manufacturing process (Drug Substance and Drug Product), clinical supply, formulation, device, packaging, and analytical development. Our daily work also includes compiling of regulatory documents and the transfer of development projects to commercial manufacturing.
We are striving for a caring and sensing network organization which lives a culture of trust and collaboration. Our smart people drive innovation through their expertise, passion and "getting it done" mentality. The benefit for the patient is in the centre of our thoughts and efforts.
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. Our activities span a range of engineering disciplines from the requirements definition phase through to commercialization and marketed product support. Roche is recruiting for a Senior 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 Pre-Fillable Syringe Engineering group within the Device and Packaging Development Department combines design, engineering, testing, and manufacturing to develop reliable and safe drug delivery devices that meet the needs of patients, healthcare providers and Health Authorities.
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.
The primary responsibilities of this role are:
- Serving as primary packaging expert on technical development teams to provide the best-in-class containers and drug delivery devices for our medicines
- Act as project leader to successfully bring drug-device combination products and medical devices to the market
- Forecast and plan resource demands for device development projects. Execute projects within the agreed time, quality and cost constraints, resulting in state-of–the-art drug delivery devices
- Evaluation of new and breakthrough technologies. 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
- Apply your knowledge of the regulatory landscape to ensure standard compliant designs (e.g. ISO 13485, 21CFR820, ISO14971 and 21 CFR 820.30)
- 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
The successful candidate will bring the following qualifications and background:
- University level education (engineering / science degree or related discipline) and minimum 10 year 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) or similar working practices
- Experience in technical project leadership combined with a sound knowledge of legislation, regulation, industry standards and guidance within the area of combination products and medical devices
- 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
- Excellent documentation, presentation and interpersonal communication skills with an excellent command of English language and proficiency in German preferable
Roche is an equal opportunity employer.Technical Development, Technical Development > Medical Device Technology Development