Dieses Jobangebot ist archiviert und steht nicht mehr zur Verfügung.
Vakante Jobangebote finden Sie unter Projekte.
Vakante Jobangebote finden Sie unter Projekte.
Validation Engineer
Eingestellt von Vivid Resourcing Ltd
Gesuchte Skills: Engineer, Engineering, Support
Projektbeschreibung
A pharmaceutical client of mine is looking for a validation engineer to fill a role in Brussels. The contract is originally a 6-month contract with opportunity for an extension, the rates are decided on a case-by-case basis but are roughly €90- €100.
As a Validation Engineer you will ensure the delivery of a fully compliant (Quality and H&S) qualification and validation of manufacturing equipment, process, computerised system, facility/utility and cleaning validation on site.
The position will require having experience across the projects life cycle:
- URS, DQ, FAT, SAT, IQ, OQ, PQ, PV, CSV, CV, CPV and be comfortable working under own autonomy as well as working in a collaborative capacity with cross functional teams.
- Review existing validation documentation and both generating and executing validation protocols for existing and new equipment with associated facility.
- Develop, review, approve protocols for equipment, facility, utilities, computer system, and cleaning validation.
- knowledge of SPC's, Statistical analysis using Minitab
- Write validation reports
- Ensure the validation activities are delivered in a timely manner and are aligned with current GMP regulatory requirement
- Carry out engineering studies and document
- Ability to identify improvements and implement solution following management of change procedure
- Good knowledge of the MHRA guidelines, Eudralex Annexes 15, 11, GAMP5, 21 CFR Part 11.
- Familiar ICHQ9, ICHQ10
- Carry out Quality Incidence (QI's) investigations and work on CAPA's.
- Support other department requests
- Carry out Validation Risk Assessments, FMEA's
If this sounds like a role that you or someone you know may be suited to please send an up to date CV
Vivid Resourcing are committed to equality of opportunity for all applications from individuals are encouraged regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships or any other characteristic protected by law.
As a Validation Engineer you will ensure the delivery of a fully compliant (Quality and H&S) qualification and validation of manufacturing equipment, process, computerised system, facility/utility and cleaning validation on site.
The position will require having experience across the projects life cycle:
- URS, DQ, FAT, SAT, IQ, OQ, PQ, PV, CSV, CV, CPV and be comfortable working under own autonomy as well as working in a collaborative capacity with cross functional teams.
- Review existing validation documentation and both generating and executing validation protocols for existing and new equipment with associated facility.
- Develop, review, approve protocols for equipment, facility, utilities, computer system, and cleaning validation.
- knowledge of SPC's, Statistical analysis using Minitab
- Write validation reports
- Ensure the validation activities are delivered in a timely manner and are aligned with current GMP regulatory requirement
- Carry out engineering studies and document
- Ability to identify improvements and implement solution following management of change procedure
- Good knowledge of the MHRA guidelines, Eudralex Annexes 15, 11, GAMP5, 21 CFR Part 11.
- Familiar ICHQ9, ICHQ10
- Carry out Quality Incidence (QI's) investigations and work on CAPA's.
- Support other department requests
- Carry out Validation Risk Assessments, FMEA's
If this sounds like a role that you or someone you know may be suited to please send an up to date CV
Vivid Resourcing are committed to equality of opportunity for all applications from individuals are encouraged regardless of age, disability, sex, gender reassignment, sexual orientation, pregnancy and maternity, race, religion or belief and marriage and civil partnerships or any other characteristic protected by law.
Projektdetails
Geforderte Qualifikationen
-
Kategorie:
Ingenieurwesen/Technik, Sonstiges