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Computer System Validation (CSV) Engineer - Syncade MES

Eingestellt von Quanta Consultancy Services

Gesuchte Skills: Engineer, Engineering, Support

Projektbeschreibung

- ARE YOU A CSV ENGINEER WITH SYNCADE MES EXPERIENCE?
- WOULD YOU BE INTERESTED IN WORKING ON A NEW BUILD BIOLOGICS FACILITY IN SWITZERLAND?
- IF SO, I HAVE A CONTRACT ROLE FOR YOU!

New Build 1.8 BillionCHF Biologics facility - have a contract requirement for an experienced CSV Engineer with Syncade experience.

With the equipment currently being installed, the current project is currently running behind schedule and we need some CSV Engineers to carry out the computer system validation activities related to the biopharmaceutical facilities, utilities, equipment & associated automation systems.

DUTIES WILL INCLUDE

- Preparation and execution of validation protocols involving facilitates equipment, utilities and associated automation.
- Preparation, review and approval (as required) of SOPs, validation deviations, change control, validation summary reports and associated documentation.
- Management and coordination of validation activities with internal departments, external contractors and suppliers.
- Prepare and deliver cross functional training in validation methodologies, protocols and related procedures to facilitate validation activities.
- Primary point of contact for validation related issues arising during validation activities (including protocol execution).
- Investigation of deviations/non-conformances to determine [potential] impact on product quality, validation status and associated compliance requirements.
- Provides support to commissioning activities, including review of commissioning plans, procedures, turnover packages etc. (as required).
- Represent validation as a subject matter expert (SME) in all project phases (including commissioning and qualification execution).

QUALIFICATIONS

- 8-10 years of experience in a Computer Systems Validation role in a biopharmaceutical manufacturing environment.
- Knowledge of Syncade.
- Large scale project experience.
- English fluent.

Education
Bachelor of Science Degree (BSc) in an engineering or scientific discipline.
MSc in a related discipline - advantageous.

REQUIREMENTS

- CSV within Biotech facility.
- Automation Systems/SYNCADE experience.
- CGmp/CGAMP experience.
- Strong knowledge of deviation and OOS reporting.

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Projektdetails

  • Einsatzort:

    Zürich, Schweiz

  • Projektbeginn:

    asap

  • Projektdauer:

    6 months +

  • Vertragsart:

    Contract

  • Berufserfahrung:

    Keine Angabe

Geforderte Qualifikationen

Quanta Consultancy Services