Process Engineer
Posted: 05 Jun 2022
Process Engineer Description:
Background:
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, and Clinical and Commercial functions. This role is integrated into 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.
General Information:
Start date: ASAP
Latest Start Date: 01.07.2022
End date: 12 months
Workload: 80-100%
Remote/Home Office: (flexible), on-site work required, no fully remote
Travel: No
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.
- your kledge of the regulatory landscape to ensure standard-compliant designs (e.g. ISO 13485, 21CFR820, ISO14971, and 21 CFR 820.30).:
Must haves
- Min. Bachelor's 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 kledge of product industrialization using semi- or fully-automated assembly and packaging processes
- Broad experience in 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 her kledge
- 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
We are fully committed to equal opportunity engagement and strive for diversity among our workforce.
So don't hesitate to apply. od luck.