Validation Engineer

Vitrolife Group is a global provider of medical devices and genetic services with a powerful vision – to fulfil the dream of having a healthy baby!
We are now offering the exciting possibility to join our Consumables Business Area and to be part of our great Process Engineering team.
The Consumables Business Area develops, manufactures, and distributes products to more than 110 countries from three sites; Gothenburg, Denver and San Diego. Our raw material suppliers are located globally. We also have contract manufacturing in Asia. The business area consists of three business units, Media, Disposables Devices and Genomics. The turnover in 2022 was 1.339 MSEK and is 41% of the total Vitrolife Group turnover. Consumables have colleagues all over the world from the US to Australia. The product line covers most steps in the IVF process. Examples of key products are Ovoil, EmbryoGlue, G-IVF, Rapid-I, the Sense needle, micromanipulation pipettes, IVF approved labware and EmbryoMap, setting a standard for quality and safety.
The Process Engineering department is responsible for
Developing and implementing new production processes
Driving continuous improvements on existing processes in close collaboration with all production departments
Ensuring that existing production is compliant for all our in-house production within the Consumables business area
Working with our outsourced products and the assessment and approval of our suppliers’ processes in close collaboration with our Quality Assurance, Supply Chain and Product Development department.

The job
To better meet future demands on us and our processes, both internally and externally for contract manufacturers, we are currently developing and transforming our Process Engineering department. You will be a big part of this transformation journey together with your colleagues!
The team that we are building will consist of several different competencies for example within biomedicine, biotechnique, validation, automation and mechatronic.
You will play a big role in setting up and maintain a validation process within the department to ensure compliance with regulatory requirements including:
Responsible for developing and executing validation plans, protocols and reports for both new and existing equipment and processes
Review and approve documents related to validation activities
Be part of performing risk assessments in order to identify potential hazards and implement appropriate mitigation measures
Responsible for one of our manufacturing processes and drive the work with continues improvements together with the production team.

This position requires
Bachelor or master’s degree in engineering, biomedicine, chemistry, biology, mechanic, automation or equivalent
Experiences from working with quality standards and processes (such as ISO-13485, GMP)
Extensive experience of validation, revalidation and IQ/OQ/PQ work
Very good knowledge in Swedish and English both oral and written

It would be great if you had
Experiences from similar position
Project Management experience
MedTech experience
Cleanroom knowledge

We believe that you are structured, that you can see the whole picture and are able to prioritize and meet deadlines. You are also a great problem solver and quick to find new solutions when you run into a problem.
This position requires a lot of cross-functional collaborations and responsibilities with both internal and external stakeholders from a variety of countries, introducing and implementing new improvement projects, as well as being the one that colleagues will turn to regarding validation. Because of this it is highly important that you are a good communicator and that you have a pedagogical side.
Working at Vitrolife you should enjoy a changing and dynamic environment, being able to work both independently as well as in cross-functional teams and be driven by our powerful vision - to fulfil the dream of having a healthy baby!
This is a permanent, full-time position based in Gothenburg. Travel and work from other Vitrolife sites and contract manufacturers might be part of the position.
Contact and application
Interviews will take place on an ongoing basis; the position may be filled before the last application date so make sure to apply as soon as possible.
For any questions, please contact Process Engineering Manager Patric Resare 070-164 88 82
We look forward to receiving your application!
More about Vitrolife Group
Vitrolife Group is a global provider of medical devices and genetic services. Based on science and advanced research capabilities, we develop services and products for personalized genetic information and medical device products. We are supporting our customers by improving their clinical practice and the outcome of the patient’s fertility treatment. Currently, we are approximately 1,150 people worldwide, headquartered in Gothenburg, Sweden.
Vitrolife Group’s products and services are available in more than 110 countries, through our own presence in 30 countries and a network of distributors. We are a sustainable market leader and aim to be the preferred partner to the IVF-clinics by providing superior products and services with the vision to fulfil the dream of having a baby. The Vitrolife share is listed on the Nasdaq Stockholm.