Over 10 years we help companies reach their financial and branding goals. Engitech is a values-driven technology agency dedicated.

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411 University St, Seattle, USA

+1 -800-456-478-23

Computer System Validation (CSV) Expert / Consultant

We are searching for an CSV expert to strengthen our teams in Germany and Spain.

Responsibilities and Duties

  • Overall Validation Strategy on a project as well as program level
  • Establish Validation Report (VR) and Validation Master Plan (VMP) templates
  • Generate CSV strategy and methodological approach and provide support for Test Plans and Test Specifications
  • Bridge the gap between different departments (IT, Quality and Business)
  • Working on Validation documents such as FS, URS, Risk Assessment and Traceability Matrix
  • Review and execute validation (IQ,OQ, PQ) and MBR verification procedures

Qualifications and Skills

  • Good knowledge of ISPE GAMP5, FDA CFR 21 Part 11, EU GMP Guide Annex 11
  • Eye for details
  • Basic understanding of IT/OT manufacturing architecture
  • Experience with Computer System Validation (CSV)
  • Profound communication skills
  • Structured and goal-oriented attitude
  • Professional proficiency in written and spoken English. A second language (German / French / Spanish) would be an added advantage

What we offer?

  • Dynamic and open working environment
  • Diversity of projects across Europe
  • Opportunity to work on Live projects from Day 1 (most prominent Life sciences clients)
  • Personal and professional development which helps you define your long-term career goals
  • Work with highly motivated and friendly team

Contact:

Karthik Kuncharam

[email protected]

Francisco Aguilar

[email protected]

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