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Validation Engineer
Eingestellt von Quanta Consultancy Services
Gesuchte Skills: Engineer, Engineering, Design
Projektbeschreibung
Laboratory Validation specialist supporting a small Biotech laboratory near Dublin for a 6 month contract.
The validation engineer will be responsible for the completion of 21 CFR 11 assessments on lab equipment, creation/execution of IQ/OQ documentation, creation of SOP's.
Role and Responsibilities:
* The role would require completion of 21 CFR 11 assessments on lab equipment, creation/execution of IQ/OQ documentation, creation of SOP's.
* Projects will include supporting the qualification of plant computer systems such as Delta V, new plant equipment and also up-grades to existing computer systems and equipment
* Quality review and approval of Equipment Validation Protocols including Validation Masterplans, Design documents, Process and Instrumentation Drawings, IQ, OQ, PQ protocols.
* Participate in GMP Risk Assessments and FMEA's, compliance review of Risk Assessment documentation.
* Ensure equipment changes are implemented as per change control procedures.
* Project co-ordination & communication of validation issues to team members & management.
* Maintaining an up-to-date knowledge of EMA and FDA regulatory requirements.
Requirements :
* Degree in Engineering/Science Discipline
* Experience in computer system validation essential.
* Good working knowledge of Regulations and Guidelines, GAMP 5 requirements and ISPE Guidelines.
* Experience in the Pharmaceutical industry.
* Ability to participate in cross functional teams
If this is you please apply today.
The validation engineer will be responsible for the completion of 21 CFR 11 assessments on lab equipment, creation/execution of IQ/OQ documentation, creation of SOP's.
Role and Responsibilities:
* The role would require completion of 21 CFR 11 assessments on lab equipment, creation/execution of IQ/OQ documentation, creation of SOP's.
* Projects will include supporting the qualification of plant computer systems such as Delta V, new plant equipment and also up-grades to existing computer systems and equipment
* Quality review and approval of Equipment Validation Protocols including Validation Masterplans, Design documents, Process and Instrumentation Drawings, IQ, OQ, PQ protocols.
* Participate in GMP Risk Assessments and FMEA's, compliance review of Risk Assessment documentation.
* Ensure equipment changes are implemented as per change control procedures.
* Project co-ordination & communication of validation issues to team members & management.
* Maintaining an up-to-date knowledge of EMA and FDA regulatory requirements.
Requirements :
* Degree in Engineering/Science Discipline
* Experience in computer system validation essential.
* Good working knowledge of Regulations and Guidelines, GAMP 5 requirements and ISPE Guidelines.
* Experience in the Pharmaceutical industry.
* Ability to participate in cross functional teams
If this is you please apply today.
Projektdetails
Geforderte Qualifikationen
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Kategorie:
Medien/Design, Ingenieurwesen/Technik