Validation Engineer
Walloon Brabant – Contracting
Our partner is looking for an Validation Engineer to join its team. This international company is well-known for its pharmaceuticals and vaccines.
What are your responsibilities?
You will be responsible for managing and executing product transfers to Contract Manufacturing Organizations (CMOs) in the United States, particularly for secondary activities such as filling, visual inspection, and finished product packaging.
Responsibilities:
- Assess the maturity and validation level of CMOs, including the analysis of differences in validation strategies.
- Draft and review validation plans, including those of the CMO.
- Write leveraging documents and difference analyses concerning the CMO's validation strategy.
- Review and approve validation protocols and reports.
- Verify validations included in the submission file and the CMO’s validation summary reports.
- Provide technical support, maintenance, and troubleshooting at the CMO.
Who are you?
- Convincing experience in the field of validation.
- Strong communication skills and excellent proficiency in both French and English (project involving sites in the USA and Italy).
- Ability to work in a matrix organization.
- Experience with CMOs and in filling and visual inspection activities is a plus.
- Previous experience at GSK is highly appreciated.
Skills and Assets:
- Excellent communication and teamwork skills.
- Perfect bilingual proficiency in English and French.
- Ability to assess and analyze CMO validation strategies.
- Aptitude for rigorously drafting and reviewing technical validation documents.
What can you expect?
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.
