- Lead, plan, coordinate and/or perform validation and qualification
- Perform qualification and validation test of equipment, process, method, system, and/or instruments
- Issue and review validation plans, protocols and reports
- Investigate deviations and follow up with CAPA
- Define manufacturing processes, equipment, method, system, and/or instruments
- Create or support the creation of URS
- Define, write, review, update validation documentation, perform validation activities, such as validation assessments, validation plans, FAT&SAT protocols, IQOQPQ protocols and reports
- Risk analysis and management
- Initiate and manage change management operations
- At least Bachelor degree in a relevant science/technical field; e.g. Pharmacy, Biology, Chemistry or Engineering
- At least 2 years of experience with validation and/or qualification within the pharmaceutical industry
- Ability to demonstrate knowledge in GxP
- Ability to work independently under your own initiative
- Good communication and presentation skills
- Problem solving skills
- Fluent in Swedish and English in both written and speech
- Knowledge in SAP, LIMS
- Knowledge of automation, CSV, 21CFR11 and GAMP5
- Cleaning validation (CV) and/or work in clean rooms
- Sterilization and Aseptic experience
- Good experience of Change Control
- Qualification of process equipment, packaging or analytical instruments IQ/OQ/PQ,
- Excellent knowledge of interpretation of the demands in Eudralex and FDA.
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Validation Engineer - Södertälje, Södertälje kommun, Sverige - ALTEN Sweden
Beskrivning
As a Validation consultant in ALTEN, you 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 person, it is important that you are flexible, driven, accurate, efficient, helpful and 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 a 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
Essential Requirements (Education and Experience)
Valuble Qualification and Experience
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
