Validation Engineer GMP

Takara Bio Europe AB, a part of Takara Bio group, is focusing on stem cell-derived products and services for cell therapy/regenerative medicine, drug discovery and disease modelling. Specifically, the company possesses broad expertise in human pluripotent stem cells, including both hiPSC and hESC and related media. The company leverages long-standing experience in stem cell handling with leading expertise in differentiation of cells into mature and functional human cells, such as beta cells and hepatocytes. Takara Bio Europe AB has a GMP facility for production of pluripotent stem cell lines intended for use in cell therapy. The company is located in Göteborg, Sweden.

About the position
We are searching for a driven person that has experience from working with GMP documentation and validation. The right person should be able to plan, execute and document validation independently. As this assignment dosn't require that the person works from the office, you can work remotely.
The consultant assignment is for five months and the candidate should be able to start as soon as possible.
We look forward to receiving your application!

Your profile
• Relevant education such as an engineering degree or a life science profile.
• > 3-5 years relevant experience from Life Science.
• Knowledge about validation and quality assurance.
• Experience from relevant framework and guidelines in GMP, GAMP5.
• Knowledge and experience in 21CFR part 11, Eudralex vol. 4 annex 11 and GAMP 5 or other relevant framwork.
• Experience in validation of computerised systems in Life Science.

Om verksamheten



About the organisation
This is a consultant assignement at Takara Bio Europe AB in Gothenburg for five months. During that time you will be hired by QRIOS. QRIOS Life Science can offer several opportunities for skilled people with a background in biochemistry, chemical engineering or science. We work with Sweden’s leading pharmaceutical and life science companies. So whether you’re interested in research, regulatory affairs, quality assurance, environmental and quality control, sales and marketing, or just want a career change, we have the job for you.

Working as a consultant suits whoever wants to get a lot of experience in a short period of time. We offer you the chance to work with well-known brands at renowned companies where you can develop your skills. If you’re looking for a world of exciting assignments and new contacts, you’ll like being a consultant.


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