- Driving force of technical project tasks in collaboration with team members and suppliers
- Responsible for the commissioning activities, including the ownership for the user requirement specification, FAT and SAT
- Coordinating machine installations and verification activities
- Supporting validation (IQ, OQ, PQ, PV etc.) and risk management
- Managing and projects to increase the production efficiency
- Contribute to the improvement of equipment capacity plans, used in the strategic planning of site development (Site Master Plan and Business Continuity Management)
- Continuous development of the work routines and procedures in Thermo Fisher Scientific Keys to Success:
- Engineering degree in mechanics, process engineering, biotechnology or similar
- Experience (3-5 years) as team member or leader in investment projects and machine projects (preferably reagent manufacturing, assembly, packaging and labelling)
- Ability to understand the manufacturing process and product design conditions, to translate the business needs into user requirements and to identify improvements
- Experience from working in a regulated environment and familiar with GMP, IVDR and ISO 13485
- Good language skills in German and English, both written and spoken
- Excellent interpersonal and communication competence
- Motivated problem solver with the ability to manage details but also to see the big picture
- You are open-minded and show flexibility and act agile in a changing environment What we offer:
- Employment with an innovative, future-oriented organisation
- Outstanding career and development prospects
- Company pension scheme and other fringe benefits
- Exciting company culture which stands for integrity, intensity, involvement and innovation
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Project Engineer - Freiburg im Breisgau, Deutschland - Thermo Fisher Scientific
Beschreibung
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD.Location/Division Specific Information
Phadia is the leading supplier of fully automatic blood analysis systems for allergy and auto-immune diseases. With our innovative products, we set standards worldwide and assist clinicians in providing fast and reliable diagnoses, thus helping patients at an early stage. Phadia GmbH in Freiburg is the German subsidiary of the Immunodiagnostics division of Thermo Fisher Scientific, a global company that develops, manufactures and distributes in vitro diagnostics in the field of allergy and autoimmune diagnostics. Our customers expect a consistently reliable and high standard of quality from our products, which we ensure through innovative biochemical and medical technology solutions as well as highly qualified and motivated employees.
A Day in the life:
With a constantly growing product portfolio and production volume, we need to continuously invest in new machines and expand our facilities, as well as accelerating our productivity improvements. As Project Engineer within our "Operations Strategy & Projects" department you will belong to a growing team which leads and implements the project pipeline.
You will be the technical lead in cross-functional project groups together with engineers from production, validation, R&D, quality, supply chain, sourcing etc. The colleagues are mainly based in Freiburg, Germany, and you will collaborate with many international contacts to external suppliers, to our division in Uppsala, Sweden, as well as within Thermo Fisher Scientific globally.
Typical duties and responsibilities: