CSV Engineer - French/English

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GXP Consulting Switzerland

Permanent contract

Lausanne, Switzerland

90 - 110 kCHF without variable

Key points

  • more senior profiles could be accepted
  • the candidate must be willing to work in Switzerland
  • at least 3 years of experience in the field of computer system validation that you developed in Pharmaceuticals, Biotechnologies or Medical devices industries

 

Description of the job
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 
• You work independently and successfully solve problems and complete/qualify a system within given constraint 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

Ideal profile
• 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 that you 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 experiences 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 with good knowledge of English
• You are willing to work in Switzerland 

Expected skill:

Pharmaceuticals
Medical Devices
Computer System Validation
Biotechnology

Languages required


Languages Level Frequency of use 
French Professional Daily Yes 
English Professional Frequently Yes

Type of position
Consulting
Permanent contract
Work place
Lausanne, Switzerland
 Basel, Switzerland
 Neuchâtel, Switzerland
 1800 Vevey, Switzerland
Level of education
Minimum education : Master's degree

Experience : More than 3 years

Current gross salary 
90 - 110 kCHF without variable

Salary over 13 months

Advantages
 Remote 
 Others 
Very competitive compensation package with exceptional Pension scheme - 5 weeks paid holidays - ongoing Training & Development opportunities.

Information

link http://gxp-cs.com

sell Consulting

people  55 collaborators

public Outreach national

place Headquarters Lausanne, Switzerland

The company

GXP CONSULTING Switzerland is a Swiss company composed of a passionate team of experienced Life Sciences professionals. Since 2014 we deliver outstanding industry’s expertise and support to our clients in the complete product life cycle such as: R&D, Engineering and Construction, Quality management (Quality Assurance, Qualification/Validation, QC,…), Regulatory Affairs, Manufacturing, Maintenance, Operational Excellence, and Project Management. We are a well-known and recognized leader in the Life science market thanks to our deep industry knowledge and trust we developed with our customers over the years. Our in depth understanding of the local culture and market makes us agile and proactive which means that we can adapt ourselves to any context and specially yours. Such a positioning confers us a specific ability to anticipate new trends in our industry. As GXP CS is being lead by people who place the human above everything else, by joining us, you will integrate a very interesting and caring environment, totally independent of any group or shareholders. We were created by people like you who want to boost our career, while caring about people, thinking out of the box and proposing innovative approaches and solutions.

Corporate culture

• We are a 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 • We work as a team where every member is valued and appreciated. • We propose continuous learning and development opportunities via internal or external training and workshops. • We offer a competitive salary package in line with industry practice together with exceptional employment benefits.

Contact: hr@globaljobservices.vn

Whats app: +84375495462

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