Pharmaceutical Equipment Qualification and Validation Officer (M/F)
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Machine translation — original language: French.Show original
Joining Meent means?
Joining an expert engineering company in Life Science, created in 2023, which values the talent and energy of its employees to carry out innovative and ambitious projects.
At Meent Life Science, we build an adventure with our employees based on:
Mutual aid and team spirit Benevolence and stability Fulfillment and professional progression
We believe that a fulfilled employee is a high-performing employee. That is why we offer a stimulating environment, training opportunities, and long-term support in your career.
The position:
- Write and review qualification/validation strategies for installations / production equipment / utilities
- Perform risk analyses
- Elaborate technical documents: qualification/validation master plan, protocols, test sheets, reports
- Supervise and follow the coordination of qualification phases (FAT/SAT/QI/QO/QP)
- Participate in various tests in collaboration with technicians
- Manage non-conformities, change control, investigations, deviations, and associated actions
- Approve results and rule on the qualified/validated status
Profile sought:
- With a Bac +5 education, Engineer or Master's degree, you have significant experience in qualification / validation in a pharmaceutical environment
- You have already performed the qualification / validation of production equipment and you master the associated techniques: FAT/SAT/QI/QO/QP
- You master regulatory requirements (GMP/BPF, ISO 13485...) and current standards
- You are comfortable with English and are able to write technical documentation.
- You are adaptable, curious, rigorous, and possess good interpersonal skills.