CSV Engineer

Are you passionate about and experienced in the field of validation and computerized systems? Join us and get the future you want!

We are currently looking for a person specialized in the field of validation of computerized systems (CSV) to our newly formed Compliance Quality & Regulatory team in Gothenburg, where you will have the opportunity to influence the direction and way of working of the team in Gothenburg from start.
Capgemini Engineering offers you a work environment that is characterized by innovation. As a consultant at Capgemini Engineering, you are part of something bigger. Together with our partners we are facing exciting challenges whilst creating the future.

As a CSV Engineer at Capgemini Engineering , you will be part of the Swedish Quality, Regulatory & Compliance community, taking the efficiency, quality and compliance of our partners to the next level in order to develop smarter products and become an even stronger player within the life science and medical device industry.
We help our clients with implementation and validation of new systems as well as validation of existing systems. We also lead improvement projects, where validation processes and other related areas need to be aligned with the business and the regulations. As a CSV-engineer you will be involved in activities on an operational and strategic level. You can choose to challenge yourself by joining global complex projects, or work with smaller local clients and start-ups, becoming the guiding star.

You could be responsible and actively involved in all different tasks throughout the validation phases, including writing URS, performing supplier and system evaluation, risk management, writing instructions and procedures in accordance with current regulations and guidelines, creating test protocols, and compiling plans and reports. Other assignments can involve training and other specific areas of improvement such as Cost of Quality & Right first time. Internally, you may be involved in the bid and sales process for CSV-projects.

Your Profile
We are looking for you with a great interest in validation of computerized systems who want new challenges and want to be able to contribute even more by working as a consultant at one of Europes leading companies in innovation consulting.

We believe that you currently have a role as a validation engineer or quality specialist with several years of experience from validation of computerized systems within the Life Science Industry, working for pharmaceutical and med-tech companies. We see that you have extensive experience in validating smaller and larger computerized systems according to current regulations, guidelines and standards and that you don’t fear challenges, nor responsibilities. Since you will usually work in a group, it is important that you are outgoing as well as enterprising. The work may take place on the international stage so the ability to communicate in speech and writing in English is a requirement as well as a valid work permit for Sweden.

We believe that it is meritorious if you have had a leading role within validation projects, such as validation lead or project manager.
At Capgemini Engineering we value excellence, care, responsibility, dynamism and innovation. We offer a job with variation that leaves plenty of room for initiative and development. In fact, we are not just offering you a job, we’re inviting you to be part of our community where we will provide you trainings, tools & grounds for professional and personal growth. Each career experience is assorted by an attractive salary package.