Cleaning Validation Analyst

Pauwels Consulting

Puurs-Sint-Amands

On-site

EUR 40,000 - 55,000

Full time

3 days ago
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Job summary

Pauwels Consulting in Belgium seeks a Cleaning Validation Analyst to plan, execute, and report validation studies for cleaning processes of drug products, supporting both operations and projects while upholding GMP compliance and quality.

Applicants should hold a bachelor’s degree in industrial pharmacy, bio‑engineering, or a related engineering field, have 1+ year in Cleaning Validation, strong technical writing skills, PC software skills, and fluent Dutch and English.

Qualifications

  • Bachelor's degree in industrial pharmacy, bio-engineering, or related engineering field.
  • 1+ years of Cleaning Validation experience within a GMP environment.
  • Proficiency in technical writing and PC software applications.
  • Fluency in Dutch and English.

Responsibilities

  • Draft protocols and reports for cleaning validation and risk assessment studies.
  • Schedule and execute routine cleaning qualification studies.
  • Analyze results to ensure adherence to operational standards.
  • Assist with validation for planned product and process changes.
  • Investigate quality issues and contribute to lifecycle management.
  • Monitor cleaning processes to ensure ongoing effectiveness and compliance.

Skills

Technical writing
Problem solving
Organized working style
Dutch
English

Education

Bachelor's degree in industrial pharmacy
Bachelor's degree in bio-engineering
Related engineering field

Job description

Our client, a leading pharmaceutical organization, is seeking a Cleaning Validation Analyst to manage the planning, execution, and reporting of validation studies. This role supports both operational and project teams by ensuring the effectiveness and compliance of cleaning processes for drug products.

  • Draft protocols and reports for cleaning validation and risk assessment studies.
  • Schedule and execute routine cleaning qualification studies.
  • Analyze results to ensure adherence to operational standards.
  • Assist with the practical preparation and reporting of validation for planned product and process changes.
  • Investigate quality issues and contribute to lifecycle management.
  • Monitor cleaning processes proactively to ensure ongoing effectiveness and compliance.
  • Bachelor's degree in industrial pharmacy, bio-engineering, or a related engineering field.
  • 1+ years of experience in Cleaning Validation within a GMP environment.
  • You bring proficiency in technical writing and PC software applications.
  • You have strong problem-solving abilities and an organized, accurate working style.
  • You are fluent in Dutch and English.
Nice to Haves
  • Willingness to work in a shift system.
  • Experience with risk assessments and deviation management.
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