Beschreibung
Process Engineer Device and Packaging Development (f/m/d)- German /English / manufacturing technologies /industrialization/ pharmaceutical industryProject:
For our customer a big pharmaceutical company in Basel we are looking for a highly qualified Process Engineer
Background
Pharma 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.
"Europe Biologics"(PTDE) supports biologics from Phase I to the Market. Our activities encompass process development for Drug Substance (DS) and Drug Product (DP), market formulation design and process development, device and packaging development, clinical manufacturing of DS and parenteral DPs, analytical method development, validation and release of clinical supply, development documentation submissions and transfer of development projects to commercial manufacturing.
The Device and Packaging Development Department within Roche Pharma Technical Development is responsible for the development and support of drug delivery devices and packaging solutions for the product portfolio. Our activities require a multidisciplinary team of engineers to cover development from the initial phase up to commercialization and post launch support. Roche is recruiting to support the development and maintenance of drug delivery devices (e.g. Prefilled Syringes with Needle Safety Devices, Autoinjectors, high-volume Patch Injectors, Oral Delivery Devices).
The Process Engineering group combines design for manufacturing, process design, equipment definition, design transfer and manufacturing to develop and commercialize 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 including QA, Regulatory Affairs, Clinical and Commercial functions. This role is integrated in the Device and Packaging Development Department.
The perfect candidate:
We are looking for a young talent who is keen and eager to learn new things from a manufacturing/engineering part and who has already some experience in this industry. The perfect candidate has a technical flair and hands on experience in semi- or fully-automated assembly and packaging processes.
Tasks & Responsibilities
* Support design transfer projects for portfolio products within the agreed timelines and quality requirements.
* Author scientific reports, memos, and rationales related to design transfer, risk management, and control strategy documentation.
* Plan, design, execute and document testing within the framework of process design and combination product verification activities
* Collaborate effectively with broad cross-functional internal and external teams in developing strategies and concepts for the manufacturing of medical devices and combination products.
* Ensure the qualification and validation of processes and equipment in collaboration with internal V&V specialists.
* Apply your knowledge of the regulatory landscape to ensure standard-compliant designs (e.g. ISO 13485, 21CFR820, ISO14971 and 21 CFR 820.30).
Must haves:
* Min. Bachelor degree in engineering or related discipline
* Min. 2-5 years of experience in product commercialization or process engineering /industrialization, preferred in the pharmaceutical industry
* Hands-on knowledge on product industrialization using semi- or fully-automated assembly and packaging processes
* Broad experience on manufacturing technologies for low and high-volume applications (e.g. assembly, packaging, injection molding, machining, marking, printing, gluing, sealing, welding)
* Technical/ Digital Flair
* German and English fluent needed
* Person that can learn quickly and is keen to broaden his or hers knowledge
* Enthusiastic team player
* Communication skills
Nice to haves:
* Experience with ISO 13485, 21CFR820, ISO14971 and 21 CFR 820.30 regulations is a plus
* Experience in an equipment supplier for a pharmaceutical company or CMO // Medical Device environment
* Experience in working in a project environment, preferred experience in project management
* Experience of working in pharma or other closely-regulated environments is preferred
* Previous Roche experience
Reference No.: 921459TP
Role: Process Engineer
Industry: Pharma
Location: Basel
Workload: 100%
Start: ASAP
Duration: 12++
Deadline: 09.06.2022