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CHE-106.649.671 Fisher Clinical Services GmbH
last mo.

Senior Engineer CSV(m/w/x)

Lengnau
Full-timeOn-siteSenior

Description

In this role, you will play a crucial part in shaping the future of the Automation department by ensuring cGMP compliance and maintaining high-quality standards. Daily activities will involve collaborating with various teams, managing inspections, and implementing effective validation strategies.

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Requirements

  • •Adherence to Good Manufacturing Practices (GMP) Safety Standards
  • •Proven expertise in CSV

Work Experience

approx. 4 - 6 years

Tasks

  • •Assist in deploying and overseeing quality systems for cGMP compliance
  • •Ensure a unified approach to systems validation in the Automation department
  • •Support Manufacturing Engineering management with CSV activities
  • •Maintain validation of cGMP Execution Systems in an inspection-ready state
  • •Act as a delegate for internal and external CSV inspections and audits
  • •Manage deviations within the Automation department
  • •Track GMP trends to implement effective CSV practices
  • •Define validation strategies for computerized systems
  • •Collaborate with peers in Automation, IT, Quality Management, and Engineering
  • •Serve as a liaison between departmental teams and the DI officer
  • •Conduct regular DI Surveillance through Gemba Walks and trainings

Languages

English – Business Fluent

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