ALTEN Belgium is a leading consultancy company in the fields of Engineering, Life Sciences and IT in which our people and clients are central.
In our open and adaptable organization, we get the best out of our ambitious employees enabling them to perform optimally. We do this by offering them the most challenging projects, but also to continuously acquire new expertise to boost their careers. This can be done with the help of our ALTEN Academy, but also through our knowledge sharing events.
All employees together form a large network of expertise, even at an international level. In this way we offer optimal growth to our consultants and the best solutions for our customers.
Do you want to work in exciting projects at renowned clients? At ALTEN we believe that knowing and meeting the expectations of our consultants is a key factor in our success. Our consultants make the difference. Do you want to make the difference too?
We are currently looking for a Process Validation Engineer Cell Therapy to join our team.
Main responsibilities
* Define strategy, plan, and coordinate validation activities such as sterilization, hold time validation, APQ and APS
* Provides guidance on aspects of validations and qualifications
* Assure revalidation of manufacturing and sterilization processes
* Write, review and approval of sterilization-, APS and other related validation plans, protocols and reports
* Participate in product transfer and system introduction teams
* Participate in system and process improvement / optimization projects
* Reviews technical reports and other sources of information to ensure that validations and procedures are consistent with current industry, regulatory requirements, and current technology
Your profile
* Experience in the Pharmaceutical, Biotechnology, Cell Therapy, human plasma derived products or related industry is required.
* Experience with introduction of pharmaceutical products to manufacturing sites and late state development with working technical knowledge of manufacturing site unit operations
* Strong working knowledge of current Good Manufacturing Practices (cGMP)
* Experience working in a controlled, cleanroom environment under aseptic conditions is a plus, but not a must
* Project Management - provide timely and accurate reporting on project activities to peers and leadership
* Ability to interact at different levels of the organization
* Ability to work under pressure, handle conflicting interests, and take decisions
* Ability to work independently under general direction, having a good sense of prioritization of assigned tasks goals and manage time accordingly
* Team player
* Problem solving skills and attitude
* Fluent in written and spoken Dutch and English
* 5 - 7 years previous experience
* A Bachelor's degree or higher in engineering, biotech, biomedical sciences or pharmacy is required
What ALTEN has to offer
* A permanent contract
* A salary package in line with your experience and extra benefits (company car, meal vouchers, recovery days, insurances)
* The possibility to join a great team and be part of the success story of an international group
We are also open to work with freelancers
Apply now and be a part of our amazing journey. We believe in growing together
We are looking forward to getting to know you and your ambitions