Ingénieur(e) Qualification/validation

Stryker Corporation

Lyon, France
Hybrid
Validation and qualification projects
Computerized system validation (csv)
Equipment qualification (eq)
Stryker Corporation is seeking an Ingénieur(e) Qualification/Validation in Lyon, France, to ensure compliance and performance standards in their systems and processes. The role emphasizes collaboration and requires strong technical expertise in validation methodologies, regulatory requirements, and documentation

Job Summary

  • Pilot validation projects, including equipment qualification, computerized system validation, and building/facility/utility qualification, in compliance with global and local standards.
  • Ensure robust and compliant validation documentation throughout the lifecycle, utilizing tools like eVLMS ValGenesis.
  • Contribute to remediation projects, proactively identify improvement opportunities, and ensure adherence to FDA, ISO, and GMP requirements.

Matching Summary

Match Score: 85

Stryker Corporation is seeking an Ingénieur(e) Qualification/Validation in Lyon, France, to ensure compliance and performance standards in their systems and processes. The role emphasizes collaboration and requires strong technical expertise in validation methodologies, regulatory requirements, and documentation.

Skills & Requirements

Must-have

  • Validation and Qualification projects
  • Computerized System Validation (CSV)
  • Equipment Qualification (EQ)
  • Validation documentation (FAT, SAT, IQ, OQ, EQ, MSA)
  • Statistical analysis and quality tools
  • Root cause analysis and CAPA
  • FDA, ISO, and GMP compliance

Nice-to-have

  • Collaborative and cross-functional environments
  • Continuous improvement initiatives
  • Proactive opportunity identification
  • Culture of quality, safety, and innovation

Key Requirements

  • Engineering degree (mechanical, automation, etc.) or higher education in medical science, quality, or equivalent
  • Good knowledge of regulatory requirements (FDA, ISO, GMP)
  • Solid mastery of validation methodologies and statistical tools
  • Proven experience in writing and managing validation documentation
  • Experience with problem-solving and root cause analysis methodologies
  • Excellent interpersonal and communication skills
  • Professional French and English proficiency

Work Rights

Not specified

Tailored Resume

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