Validation and regulatory engineer
Location: BelgiumSIRE Life Sciences® is the market leader in life science recruitment. We believe the recruitment market needs to gear up in technology and continues innovation. We like technology, in a life science market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!
THE COMPANY
Our client is a professional Pharmaceutical organization, based in Antwerpen Belgium.
You will work at a company with a high purpose. They believe all people deserve to live healthy lives. This drives their desire to provide access to medicines that are safe, effective, and affordable.
ROLE DESCRIPTION
You are involved as validation and registration engineer in investment projects for modifications and new installations. In your role you focus on product quality and compliance, guide the project team and ensure general awareness. Within your department, you evaluate the validation and registration impact in change controls with each change. You work together with the technical experts on a validation plan and do the final review of all system validation reports. You coordinate together with global registration colleagues and the experts of the site the preparation of a new registration dossier for new submissions and modifications to existing registration dossiers.
RESPONSIBILITIES
in this role you are responsible for monitoring the validation and registration approach for all equipment (filling lines, autoclaves, inspection machines, HVAC, computer systems, lab systems, ...) of a complete production unit. You are the contact point and the quality authority for validation and compliance within this production unit. Next to that you are responsible for the following:
- An active part of a team project engineers quality and sharing knowledge
- The contact person in the team for certain processes (eg HVAC, sterilization, calibration, ...) for which you build up expertise through contacts with the departments involved
REQUIREMENTS
MSc Bio-Engineer, Industrial-Pharmacist or Industrial Engineer ( or other relevant education)
You have a broad field of interest with a natural affinity for quality and processes
You have the necessary assertiveness to defend your positions
You work towards solutions
You can make decisions, and you actively consult with colleagues about problems
You always keep a "helicopter view" and are able to dive into the details when necessary
You are stress resistant
You preferably have several years of work experience in at least one of the following environments:
- Engineering in a GMP environment
- Quality department
- Testing and validation
Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Valentijn de Krom.
