Specialist (m/w/d) Cleaning Validation

Roche

Penzberg, Germany
Onsite (minimum 50%)
3+ years experience in chemical production
Fundamental knowledge of gxp regulations
Experience with iso13485 standards
Roche is seeking a Specialist in Cleaning Validation for its Diagnostics Operations in Penzberg, Germany. The role focuses on ensuring compliance with quality standards and involves collaboration on large investment projects, requiring relevant experience in validation processes and a strong understanding of applicable regulations

Job Summary

  • This role ensures Quality Compliance for Diagnostics Operations Penzberg by managing validation and verification of cleaning procedures for process plants.
  • The position involves active participation in large investment projects (CAPEX) while collaborating closely with QA, MSAT, and Production stakeholders.
  • Candidates must possess at least three years of relevant experience in chemical production and specific prior experience in cleaning validation within the pharmaceutical or diagnostic sectors.

Matching Summary

Match Score: 85

Roche is seeking a Specialist in Cleaning Validation for its Diagnostics Operations in Penzberg, Germany. The role focuses on ensuring compliance with quality standards and involves collaboration on large investment projects, requiring relevant experience in validation processes and a strong understanding of applicable regulations.

Skills & Requirements

Must-have

  • 3+ years experience in chemical production
  • Fundamental knowledge of GxP regulations
  • Experience with ISO13485 standards
  • 21 CFR Part 820 compliance expertise
  • Project management skills in CAPEX projects
  • German C1 language proficiency required

Nice-to-have

  • Passion for modern quality management
  • Ability to work onsite 50% of time
  • Strong stakeholder communication skills
  • Experience in diagnostic industry
  • Structured working methodology

Key Requirements

  • Bachelor's degree in natural sciences or equivalent
  • Minimum 3 years in chemical production
  • Mandatory experience in cleaning validation
  • Fluent German (C1) and good English skills
  • Knowledge of GxP, ISO13485, 21 CFR Part 820

Work Rights

Not specified

Tailored Resume

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