Validation Engineer/CSV Engineer - Life Sciences

We are now looking for new colleagues who want to work together with us and develop themselves as a Validation consultant in our Life Sciences team in the greater Stockholm-region! As a Validation consultant at ALTEN, you'll work with different interesting customers that we support in the pharmaceutical industry. We aim to make a difference for our clients as well as their end users, the patients! Our clients and colleagues are located in Stockholm, Uppsala, Södertälje and Strängnäs.As a consultant, it is important that you are flexible, driven, accurate, efficient, helpful and well-structured while being social and a team player. You must be able to plan, prioritize and perform your tasks independently and in a solution-oriented way.As an ALTEN consultant, you have a great chance to impact your own development! Once you get some seniority we have great opportunities to develop you into expert roles as well as working in teams and work packages.The role:Lead, plan, coordinate and/or perform validation and qualificationPerform qualification and validation test of equipment, process, method, system, and/or instrumentsIssue and review validation plans, protocols and reportsInvestigate deviations and follow up with CAPADefine manufacturing processes, equipment, method, system, and/or instrumentsCreate or support the creation of URSDefine, write, review, update validation documentation, perform validation activities, such as validation assessments, validation plans, FAT&SAT protocols, IQOQPQ protocols and reportsRisk analysis and managementInitiate and manage change management operationsEssential Requirements (Education and Experience):At least Bachelor degree in a relevant science/technical field; e.g. Pharmacy, Biology, Chemistry or EngineeringAt least 2 years of experience with validation and/or qualification within the pharmaceutical industryAbility to demonstrate knowledge in GxPAbility to work independently under your own initiativeGood communication and presentation skillsProblem solving skillsFluent in Swedish and English in both written and speechValuable Qualification and Experience:Knowledge in SAP, LIMSKnowledge of automation, CSV, 21CFR11 and GAMP5Cleaning validation (CV) and/or work in clean roomsSterilization and Aseptic experienceGood experience of Change ControlQualification of process equipment, packaging or analytical instruments IQ/OQ/PQ,Excellent knowledge of interpretation of the demands in Eudralex and FDA.About ALTEN:ALTEN is one of Europe’s largest consulting companies within Engineering, IT and Life Sciences with over 54,000 employees in more than 30 countries. We’re a global actor with a local presence with 1400 committed colleagues in offices from Lund in the south to Skellefteå in the north. Our engineers carry out complex and highly technical projects throughout the product development chain of the most prestigious companies in sectors such as Automotive, Aerospace & Defense, Energy, Manufacturing, Public Sector and Life Sciences.For four years in a row, ALTEN has been named one of Sweden's most attractive employers by Karriärföretagen, an award for employers that offer unique career and development opportunities. Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you! Building tomorrow's future today!