CSV Engineer

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 expertise and support to our clients in the complete range of product life cycle in the following areas:

R&D, Engineering, Quality Assurance, Qualification/Validation, Regulatory Affairs, Operational Excellence, Manufacturing, Maintenance, and Project Management.

About the job:

• You provide support and expertise on Computer System Validation activities
• You run CSV projects execution ensuring timelines are met
• You write validation plan, URS, FS, risk assessment, IQ/OQ/PQ protocols, reports, VSR, applicable SOPs and training documents
• You train and coach people
• You maintain expertise in current and emerging cGMP requirements and quality trends (e.g., 210, 211, 820, and 21 CFR Part 11, GAMP, EU Annex 11…)
• You work independently and successfully solve problems and complete/qualify a system within given constraints of scope, time and schedule
• You lead system qualification efforts and are the primary client contact for coordinating work, reporting status, resolving issues, and addressing change orders as they apply
• You develop new and pragmatic approaches to support the industry in this field

About you:

• You hold a Master’s degree in a scientific or engineering discipline
• You possess at least 3 years of experience in the field of computer system validation developed in Pharmaceuticals, Biotechnologies or Medical devices industries
• You have 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)
• You have previous automation experience and experience with MES, ERP and LIMS
• You possess experience in project execution within at least one area of systems validation – e.g., laboratory equipment, facilities, utilities, manufacturing equipment, metrology equipment, information systems
• You are fluent in French and English. Fluent in German is an asset

About us:

• Human-sized company with colleagues from diverse cultural and professional backgrounds
• Open communication
• Joint team spirit
• Continuous learning and development thanks to internal trainings and workshops

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!

By Mail

Voie du chariot 3
1003 Lausanne
Switzerland
PO BOX 8009

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