CSV Engineer

GXP CONSULTING Switzerland; Lausanne; Vor Ort; CHF 110.000 - 150.000; Vollzeit

Zusammenfassung

GXP CONSULTING Switzerland is seeking a qualified CSV Engineer (IT/System or Automated Equipment) to support validation and lifecycle management of systems in production, labs, QA, or supply chain in the Lausanne area, Switzerland.

The ideal candidate has a Master’s degree in sciences or engineering with 3+ years in pharmaceutical/biotech/medical device validation, and strong GAMP5 and CSV deliverables experience, plus fluency in French and English.

Qualifikationen

• Master’s degree in sciences or engineering or equivalent experience.
• Minimum 3 years of experience in computer system validation in pharma, biotech or medical devices.
• Experience with GAMP 5 and lifecycle deliverables (URS, SRS, FRS, DDS, RTM, Unit, Integration, UAT, FAT, SAT, IQ, OQ, PQ, Final Validation Summary).
• Experience with MES, ERP and LIMS.
• Experience in project execution in at least one system validation area (lab equipment, facilities, utilities, manufacturing equipment, metrology, information systems).
• Fluent in French and English.

Aufgaben

• 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 ERP, LIMS, MES, SCADA, lab instruments, etc.
• Collaborate with IT, QA, business users, automation engineers, and external vendors.
• Maintain validated status throughout lifecycle (change management, revalidation, retirement).
• Support audits and regulatory inspections as a CSV SME.

Kenntnisse

Validation planning

Regulatory compliance

GxP knowledge

English/French bilingual

Ausbildung

Master’s degree in sciences or engineering

Tools

ERP

LIMS

MES

SCADA

Jobbeschreibung

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.

In order to continue to successfully support our clients, we are currently looking for a CSV Engineer (IT/System or Automated Equipment) with solid experience in GMP environments to support implementation and lifecycle management of systems in production, laboratories, quality, or supply chain settings to work in Switzerland (Lausanne area):

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.

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.