Validation Engineer, Validation leader to ALTEN Pharma

We are now looking for new colleagues who want to work together with us and develop themselves as a Validation consultant in our wonderful Life Science team in the greater Stockholm-Uppsala area!

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.

 

YOUR DEVELOPMENT

As a consultant, you have a great chance to impact your own development! If you feel that the business is interesting, there is a chance to develop into a Business Manager role in time. If the consultant role is more interesting, we have great opportunities to develop 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 3 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

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.

Are you already imagining yourself joining our team? Good, because we can’t wait to hear from you!

 

WHAT WE OFFER YOU

Every employee is equally valuable in the success of ALTEN! We are driven by making people grow and develop, which is why we offer you the opportunity to work with what you are truly passionate about. At ALTEN, we have a broad range of assignments at most of the leading companies in Sweden in several different sectors, to make it possible for your wishes to come true. We offer both national and international opportunities and together with your coaching manager, you build your career path so you constantly are able to develop and achieve your goals and dreams!

As a consultant at ALTEN, you will get the genuine team feeling at your assignment but also a wonderful togetherness at ALTEN. Through our different internal networks, such as ALTEN Sports, Women@ALTEN and ALTEN Innovation you will get the opportunity to drive topics and activities that are close to your heart, together with your colleagues. All activities are of course optional. Work life balance is our top priority. We also have a collective agreement and other benefits like Pension, Insurances and Wellness grants.

 

We believe in growing together!