Senior Process Engineer

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The Position

Pharma Technical Development (PTD) is an organisation 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 commercialisation and post launch support. Roche is recruiting for a Senior Process Engineer 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 commercialise 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.

Theprimary responsibilities of this role are to{{:}}

• Lead and execute design transfer projects for portfolio products within the agreed timelines and quality requirements
• Collaborate effectively with broad cross-functional internal and external teams in developing strategies and concepts for the manufacturing of medical devices and combination products
• Lead the interface between Device and Packaging Development and internal/external manufacturing sites
• Support innovation and continuous improvement activities for manufacturing processes
• Author scientific reports, memos and rationales related to design transfer, risk management and control strategy documentation
• 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)
  
  

The successful candidate will bring the following qualifications and background{{:}}

• University level education (engineering degree or related discipline) and a minimum of a 5-8 years proven track record in product commercialisation or process engineering /industrialisation
• Experience of working in pharma or other closely-regulated environments is preferred
• Sound knowledge on medical device and combination product industrialisation using semi- or fully-automated assembly and packaging processes
• Strong understanding of legislation, regulations, industry standards and guidance on combination products and medical devices (e.g. Design Control, Product Verification, Design Transfer, Process Validation, Quality Systems)
• Broad experience on manufacturing technologies for low and high volume applications (e.g. assembly, packaging, injection moulding, machining, marking, printing, gluing, sealing, welding)
• Enthusiastic team player with fluent communication skills in German and English
  
  

Please note that this is a 24 month fixed-term contract opportunity.

Who we are

At Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we’ve become one of the world’s leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.

Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche`s largest sites. Read more.

Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.

We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.

Roche is an Equal Opportunity Employer.

Job Level{{:}}

Individual contributor