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Senior Validation Engineer (CSV Global Lead)

Posted Date: 26-Oct-2021

Location: Eysins, VD, CH, 1262

Company: Quotient

Building on 30 years of experience in transfusion diagnostics, Quotient is a commercial stage diagnostics company committed to delivering solutions that reshape the way diagnostics is practiced.  Quotient has two key product portfolios, Alba by Quotient and MosaiQTM by Quotient. The Alba by Quotient product range is comprised of high-quality reagents used to keep laboratories around the world running efficiently. They are sold directly to laboratories or through our OEM partners. MosaiQ™ by Quotient is our proprietary multiplex microarray technology, offering the world’s first fully automated, consolidated testing platform, allowing for multiple tests across different modalities. MosaiQ™ is designed to be a game-changing solution, which we believe will increase efficiencies, improve clinical practice, deliver significant workflow improvements and operational cost savings to laboratories around the world. Quotient’s operations are based in Eysins/Switzerland, Edinburgh/Scotland and Newtown/Pennsylvania.

 

Senior validation engineer (CSV global lead)

 

Quotient is recruiting for a Senior Validation Engineer (CSV Global Lead) to join the Operative Quality team based in Eysins. The role is a full-time and permanent position.

 

The CSV Global Lead will be responsible for providing both technical leadership and line management across all Computerised System Validation activities completed within Quotient business units. The job holder will act as a Subject Matter Expert for CSV and all such systems which require validation. 

 

JOB DESCRIPTION
The main responsibilities will include:

  • Understands business processes / products and needs of internal / external customers and looks to align service provided with these.
  • Leads projects or project steps within a wider project and has accountability for ongoing activities and / or objectives.
  • Responsible for management of compliance during all phases of software development life cycle (SDLC).
  • Interface directly with IT, Engineering, QC, Manufacturing and QA teams to provide advice and assist in resolving compliance issues.
  • Collaborate with other Quotient sites / facilities and their internal and external partners to lead activities to ensure consistent application of software validation concepts and quality systems / processes
  • Supervision and oversight of contractors and intern activities.
  • Participation in internal and external audits (regulatory and client). Involvement, as required, as Subject Matter Expert.
  • Makes decisions and solves complex problems through taking a wider view including business and technical input to identify solutions meeting customer needs.
  • Participate in review, interpretation, approval and reporting of data trends originating from group operations
  • Acts as a resource for colleagues with less experience
  • Leads the work of small project teams and formally trains junior staff
  • Interprets internal or external issues and recommends solutions / best practices

 

QUALIFICATIONS & EXPERIENCE REQUIRED

  • Bachelor/Master degree in science or equivalent Engineering diploma.
  • Minimum 7 years CSV experience in regulated environment.
  • Validation experience in global IT softwares validation (ERP, MES, LIMS,…) applied in pharmaceutical or Medical device industries.
  • Knowledge and expertise of core IT systems.
  • Strong knowledge on European and FDA standards dealing with computerized systems.
  • Ability to work in fast moving environment, maintaining focus on goal and achievement thereof.
  • Ability to communicate in a clear and concise manner.
  • Good report writing skills and adherence to business timelines.
  • Team player, ability to work to under pressure.
  • Infrequent travel to supplier or other Quotient sites.
  • Fluent in English.