Computer System Validation Engineer (m/f)

Job type:
on-site
Start:
asap
Duration:
6 MM+
From:
Hays AG
Place:
Basel
Date:
10/13/2015
Country:
flag_no Switzerland
project ID:
1000337

Warning
This project is archived and not active any more.
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We are looking for a
Computer System Validation Engineer (m/f)

Reference: en
Start: asap
Duration: 6 MM+
Place: in Basel
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen

Your tasks:
  • Manage, co-ordinate and develop validation deliverables for a new IS project
  • Support and co-ordinate qualification and validation processes
  • Support activities include, but are not limited to the preparation of validation/qualification plans, risk assessments, user requirement specifications, traceability matrix, testing (IQ, OQ/PQ), data migration, SOPs and change controls
  • Facilitate the release of the regulated system for GxP production use in line with project timelines
  • Support the problem solving of project deviations/errors and provide quality guidance on GxP regulatory requirements (including, but not limited to 21 CFR Parts 11, 820 and EU GMP Annex 11.)
  • Participate in project teams as required
  • Responsibility for defining test strategy, designing and developing test cases according to software requirements, architecture designs, and code of complex software systems
  • Conduct validation training with project team, communicating deliverables, procedures and methods


Your qualifications
  • Bachelor's degree in Automation Engineering, Electrical Engineering, Systems Engineering, Technology or a related discipline.
  • Profound industry experience in software engineering
  • Software validation and equipment validation experience in a regulated industry (FDA 21 CFR 820, the Quality System Regulation and ISO 13485)
  • Experience in GxP computerised systems
  • Understanding of GAMP5 guidelines
  • Validation experience with ERP, CCMS/CMMS, and quality systems is preferred
  • Thorough knowledge of cGMP regulations related to CSV, including 21 CFR Part 11 and EU GMP Annex 11
  • Strong knowledge of computerized system development life cycle approach is required



Skills:
- Qualification/validation specialist