Brabant Wallon – Contracting
Our partner is looking for a Validation Engineer to join its team. This international company is well-known for its pharmaceuticals and vaccines.
As a Validation coordinator, you will be working for the Product and Process department. You will directly report to the Validation Manager and support him implementing different projects.
- Actively participate in the definition of project including (validation plan & strategy);
- Define the entire scope of the project, in charge of the planning and coordinator of the change control.
- Ensure the change control
- Collect, analyze and write the IOQ/PQ validation protocols and reports and analyze the results during PQ runs linked to the different validations
- Ensure the planning of the validations in partnership with C&M/QA and production departments + contingent (C&M)
- Ensure the communication with the different stakeholder to achieve the scope of the project
- Ensure the operational management of the technicians dedicated to the validations
- Ensure all deviations related to the implementation of the change
- Ensure the follow up/reporting of the project within the MPU and outside the MPU via the ad hoc flows of communication (PRB – TIER…)
- Ensure the follow up of the QC / C&M results for each run of validation
- Ensure the collection/transfer of the local approved documents to the RA department on time in order to ensure the file submission on time
- Ensure the review of the file preparation in partnership with the QA before the file submission to the authorities
- Schedule adherence for the project
- Success rate for validations and submission on time to avoid major impact on batch release/supply
- You hold an University Degree in biotechnology, agronomy, chemistry, pharmacist or engineering
- At least 3 years in pharmaceutical industry, in manufacturing, validation, QA
- Sound knowledge of project management
- Practical knowledge of MS project, Excel, SAP, techshare
- Fluent in English written and spoken.
- Experience in communicating to various stakeholders
- Experience in highly regulated environment
Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way.