Publicerad: 2024-10-01
Validation 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 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
VALUABLE 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.
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!
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 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
VALUABLE 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.
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!