Validation Engineer – Life Sciences

at  ALTEN Sverige

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.

VALUBLE QUALIFICATION AND EXPERIENCE

• 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.

Essential Requirements (Education and Experience)

• 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 speec

• 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

Essential Requirements (Education and Experience)

• 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