Validation Specialist W/M
Entity's description: Altran in The Netherlands
Established in 1999, Altran employs more than 150 consultants in The Netherlands and provides services to key players in Automotive, Transportation, Aeronautics, Aerospace, Industry, Energy, Life Sciences, Telecommunications and the Finance - or Public Sector.
In 2011, Altran BV’s revenue reached 18.3 M€.
The Life Sciences Practice
The Life Sciences and Healthcare industry is faced with major challenges. To remain competitive, companies must develop new growth strategies, improving their overall efficiency and innovation capacity, while complying with tightening regulatory requirements.
Altran has made a concentrated effort to gain an understanding of the underlying factors that affect our clients' performances and to provide tailored solutions to help them address these specific challenges: R&D Performance, Health Care Delivery Optimisation, Operational Efficiency & Cost Reduction, New Markets Growth and Quality Excellence.
Thanks to its business model, Altran is now positioned on projects of high added-value whose complexity requires from Altran Consultants worldwide total familiarity with advanced technologies, extensive knowledge of innovation processes, along with the open-mindedness for anticipating future needs.
The training we offer our Consultants is comprehensive and diverse to ensure all of them acquire the business, technical and professional tools they need. You will have the opportunity to fine-tune your expertise through informal training sessions on the job or on-line and through formal classes and programmes with teammates. Our trainers have the background and knowledge to adapt to your skill level, thereby ensuring you learn faster and better.
As a Consultant in the position of Validation Specialist, you will establish evidences that determine whether or not our clients’ processes, components, utilities or production equipment accomplish their intended purposes, and take appropriate actions accordingly. More specifically you will take responsibility in key validation tasks such as:
- Defining the Qualification and Validation approach,
- Establishing procedures for qualification and validation in accordance with international standards (FDA, EMA, ICH, ASTM E2500, GAMP),
- Acting as a SME with regard to qualification and validation aspects,
- Performing risk assessments (ICH, FMEA),
- Writing qualification/validation documents,
- Coordinating and executing qualification (IQ, OQ, PQ) and validation tests,
- Working in close collaboration with multidisciplinary departments (production, engineering, maintenance, QC, QA).
Altran is looking for talented people with a strong scientific background (Masters, Engineers, or PhD or equivalent by experience) with:
- At least 3 years of relevant experience in the Life Sciences industry,
- A Validation-related experience of one year minimum is required,
- Excellent communication skills,
- Proactive, rigorous and analytical frame of mind with the ability to work in an structured manner,
- An good knowledge and understanding of different QMS is mandatory,
- High proficiency in English is required for this position. Dutch would be considered as a strong asset.
Education level : 5 university years degree
Languages : English (Fluent)