We are seeking an experienced Global Validation Lead to join Elos Global IT team to lead and execute validation activities for our digitalization projects and implemented global applications.
Elos Medtech is a company in growth and in a transition phase. We are on the path of becoming a data-driven and digitalized Medtech company, focusing on building an eco-system of best of breed applications to support our business needs.
As we evolve, it becomes increasingly crucial to maintain our digital ecosystem in a validated state. This is why we are seeking a Validation Lead who can ensure that our systems and processes adhere to stringent regulatory standards and software validation requirements according to ISO13485. By joining our team, you will play a pivotal role in safeguarding the integrity of our operations.
We prioritize digitalization and here you will have a say in our direction and methods. Engage in interesting IT transformation projects, with a focus on Cloud and Integration Platform as a Service (iPAAS). Join us for a fulfilling role where you can contribute to our digitalization journey and be part of a dynamic team!
Responsibilities
? Lead and execute validation activities in global projects
? Define validation strategy
? Impact assessments
? Risk assessments (regulatory and functional)
? Define test strategy
? Documentation
? Evaluating if new releases require re-validation
Requirements
? Bachelor's degree in engineering, computer science or a related field
? 5+ years of experience of Computer Software Validation(in a medical industry)
? Knowledge about MES, ERP, iPAAS.
? Experience from working in Life Science industry.
? Detailed knowledge of FDA Standard for electronic signatures and electronic records (21 CFR Part 11) as well as the GAMP 5 approach for Software validations.
? Fluent in English, both verbal and written
? Excellent communication, problem-solving, and decision-making skills
? Bonus:
? Experience with Cloud System Validation
In this role, occasional travel is required to support various projects and initiatives
If you have a passion for validation and find yourself in the above criterias, we want to hear from you! This is an exciting opportunity to lead the validation of critical global systems that will help us to drive our business forward and achieve our digitalization strategy.
Elos Medtech is a multinational company with a presence in Sweden, Denmark, the US, China, Germany, and Switzerland. The selected candidate for this position may be based in any of the mentioned countries.