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CSV Engineer

GXP Consulting Switzerland
Epalinges, VD

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Détails de l'emploi

Qualifications

Français
Anglais
Niveau Master
Support clients
Allemand

Description complète du poste

Did you ever want to work for a company placing human at the heart of its DNA? Are you ready to make a difference? Do you feel excited about the opportunity to collaborate and share your expertise with our industry leaders? YES? SO DO WE!

GXP CONSULTING Switzerland is a Swiss company with a passionate team of Life Sciences professionals. Since 2014 we deliver outstanding industry’s expertise and support to our clients in the complete range of product life cycle : R&D, Engineering, Quality Assurance, Qualification / Validation, Regulatory Affairs, Operational Excellence, Manufacturing, Maintenance and Project Management.

Are you passionate about quality and interested in GxP environments?

Join a team where your CSV skills will make a real impact on patients' lives.

About the job :

Perform risk assessments, GxP impact evaluations, and define validation strategies (CSV plans).
Write and execute validation documentation: URS, FS, DS, IQ, OQ, PQ, validation reports.
Participate in deployment or upgrade projects for systems such as ERP, LIMS, MES, SCADA, lab instruments, etc.
Collaborate with IT, QA, business users, automation engineers, and external vendors.
Ensure compliance with regulations and industry standards (GAMP 5, 21 CFR Part 11, Annex 11, ALCOA+).
Maintain validated status throughout the lifecycle (change management, revalidation, retirement).
Support audits and regulatory inspections as a CSV subject matter expert.

About you:

Master’s degree in sciences or engineering or equivalent in experience.
Minimum 3 years of experience in the field of computer system validation than you developed in Pharmaceuticals, Biotechnologies or Medical devices industries.
Experience with all pertinent industry best practices (GAMP 5, etc.) including development and execution of all applicable system life cycle deliverables (e.g., URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report).
Previous automation experience and experiences with MES, ERP and LIMS.
Experience in project execution within at least one area of systems validation – e.g., laboratory equipment, facilities, utilities, manufacturing equipment, metrology equipment, information systems.
Fluent in French and English. German is a plus

About us:

Human-sized company with great colleagues from a large diversity of cultural and professional backgrounds
We do care about our people, communicate openly and value feedback
Work as a team where every member is valued and appreciated
Opportunity to contribute to ambitious projects within an international and multicultural environment that fosters innovation, collaboration, and professional growth.
Continuous learning and development opportunities via internal or external training and workshops
Competitive salary package in line with industry practice together with exceptional employment benefits.

At GXP Consulting Switzerland everyone contributes to our joint success and grows individually!

If you also share the same passion and values, we will be glad to hear from you! Please send us your application.

Soumettre votre candidature

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Je souhaite recevoir la dernière alerte Emploi pour les postes de ce type : lab development engineer

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