Validation and Qualification Engineer

  • Germany
  • 4000.00 - 5000.00
  • 32-40 hours
  • Bachelor degree

Client

Our client is a leading project management and engineering company for industry around the world.

Client

Our client is a leading project management and engineering company for industry around the world. Their reputation is based on forming successful partnerships with their customers, offering them innovative designs and cost-effective solutions in the context of sound judgment, strong management and technical excellence. They offer Full Service Engineering for their customers, including project and program management, purchasing, design, construction management, health and safety management, commissioning, qualification and start-up for numerous projects in various market sectors.

Requirements

  • Exceptional knowledge in the areas of qualification and validation of building, utilities, equipment, manufacturing processes and analytical and microbiological methods.
  • Knowledge in automation and computer system validation.
  • Experience quality systems.
  • Project management knowledge, leadership capabilities with respect to quality topics.
  • Experience with implementation of new pharmaceutical buildings and new line preferred.
  • Strong soft skills for the coordination and motivation of interdisciplinary teams in a matrix structure.
  • Exceptional degree of team spirit, flexibility and robustness.
  • Proficient communication skills in an English- speaking project environment, good German language skills in spoken and written.

What do you get?

  • Pension entitlement as from day one
  • Collective WGA / WIA insurance
  • NBBU / ABU collective labor agreement
  • 25 holidays days
  • 8,33% holiday allowance
  • 100% payment in case of illness after one waiting day
  • Travel allowance

Duties

  • Perform qualification and validation activities for a new production building and lines in cooperation with Engineering, Qualification, Production and the Laboratories.
  • Develop, Review and Execution of project related documentation against current GMP-requirements.
  • Planning and execution of Computerized Systems Validation (CSV) in cooperation with IT and Process Automation.
  • Lead and participate in Risk Analysis of equipment, systems and processes.
  • Issue Formal Commissioning and Qualification Plans, Protocols and Reports and support different Equipment and Systems owners by providing technical knowledge.
  • Support root cause analyses and troubleshooting activities in case of deviations from Qualification/Validation Perspective.
  • Support creation, assessment, and completion of change control cases from Qualification/Validation Perspective.
  • Contact to the overall project leaders in different departments and within the global project team to support project execution.

TAGCLOUD

CSV
#pharma
#CQV
#engineer
#validation
#GMP
#automation
#production
#commissioning
#validation
#qualification
Peter Debrichy

Interested

Send your resume to peter@tailorminds.com referring to job id (1213)

More information?

Please contact Peter Debrichy working at our office in Zoetermeer, phone number +31 6-10191580

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