CSV Engineer to Malmö

Do you want to be involved and influence the future?
Join Capgemini Engineering, a technology-driven global consulting company that is characterized by strong innovation power and one of the world's largest consulting companies with 52,000 engineer and scientist team members in over 30 countries where Capgemini Engineering Sweden focus primarily on Industry, Automotive, Finance, Public Sector, Energy and Life Science.
The Life Science division in Sweden is constantly growing and we are proud to announce that Capgemini Sweden hold a Quality Management System for Medical Devices and subsequently are certified under ISO 13485. Within the Life Science division, the emphasis is on providing our customers with services within the field of quality and regulatory. Together with our global expertise centers, we deliver solutions for both large global customers and smaller local start-ups. We are driven by meeting the customer's needs and contributing to added value. In Malmö, which is part of the Medicon Valley, we work both against the pharmaceutical industry and med-tech companies. Based on the customer's needs, we provide expertise, entire project teams, services and overall commitments. Always based on what suits the customer's own organization and challenges. Capgemini Engineering strives for diversity and a good mix of people. We welcome people from different backgrounds, ages, and experiences.
The Life Science team in Malmö offers you a good collegial atmosphere with attendant managers, all in line with Capgemini Engineering values ​​- Ambition and Care.
We care about you as a colleague and offer you a safe and favorable employment. For us, social life is important and in addition to professional development, we also offer you a variety of activities. We work to promote participation and inclusion by continuously organizing joint lunches, breakfasts, bonus programs, health scholarships, health insurance, after works, sports events and more.
As a consultant at Capgemini Engineering, you are part of something bigger!
Your role
The number of colleagues in the Capgemini Engineering Life Science Team in Malmö is steadily increasing which provides great development opportunities for you as a consultant. You can choose to challenge yourself by joining global complex projects, or work with smaller local clients and start-ups, becoming the guiding star. The important thing for us is that you are involved in projects that you find most exciting!
We are currently looking for several engineers for our organization specialized in the field of validation of computerized systems (CSV). As a CSV-engineer you will be involved in activities on an operational and strategic level. Between assignments, you may be involved in the bid and sales process for CSV-projects and within the assignment you will 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.
Our clients ask us to help their organizations with implementation and validation of new systems as well as validation of existing systems (new version etc.). We also lead improvement projects, where validation processes and other related areas need to be aligned with the business and the regulations. Other assignments can involve training and other specific areas of improvement such as Cost of Quality, Right first time, etc.
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 Europe's 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.
We believe that it is meritorious if you have had a leading role within validation projects, such as validation lead or project manager.