Engineering Validation Specialist for leading CMO
Currently collaborating with a CMO in the Netherlands to find an Engineering Validation Specialist who will be responsible for supporting efforts ensuring all critical GMP standards regarding equipment and facility systems in a manufacturing environment.
- Draft the necessary validation documentation such as IOQ and PQ protocols for the validation of GMP equipment, facility and/or systems within client Netherlands site.
- Execute validation and re-qualification activities, including CSV activities when applicable, to ensure GMP equipment, facility and/or system is continuously maintained in a validated state.
- Reporting on executed validation activities according to GDP and getting the reports approved in the Quality System.
- Schedule own tasks to be performed according to the prioritization aligned with the Validation Team Lead.
- Perform change control assessments when necessary.
- Demonstrate a thorough understanding of Cell and Gene manufacturing equipment.
- Develop validation protocols from Validation plans (where/as applicable).
- 1-5 years’ experience within the pharmaceutical industry
- Bachelors in science or technical field
Language: Proficiency in English
Location: Greater Maastricht area
Type: Freelance/ Temporary
If interested, please share your CV to email@example.com with availability for a phone call.