Sterilisation Validation Analyst

Pauwels Consulting; Puurs-Sint-Amands; On-site; EUR 45,000 - 65,000; Full time

Job summary

Pauwels Consulting is seeking a validation specialist to join a pharmaceutical client in Belgium. You will draft test protocols and reports for sterilization validation, plan validation tests for revalidations and requalifications, and investigate deviations in a GMP environment.

The role requires a Master or Bachelor in relevant engineering, 1+ years GMP experience, proficiency with standard PC software and an interest in measurement technology, plus fluency in Dutch and English and strong

Qualifications

• Bachelor or Master in Industrial, Civil, or Bio-engineering, Industrial Pharmacy, or equivalent experience.
• 1+ years of experience in GMP environments or similar projects.
• Proficiency in standard PC software and interest in measurement technology.
• Strong organizational skills and ability to work accurately and creatively.
• Fluent in Dutch and English with strong technical writing skills.

Responsibilities

• Draft test protocols and reports for sterilization validation per cGMP and regulatory standards.
• Plan and monitor validation tests for revalidations and requalifications.
• Investigate deviations or non-conformities to identify root causes and improvements.
• Maintain and update GMP documentation throughout the project lifecycle.
• Coordinate team activities and communicate progress to stakeholders.
• Support transfer of projects to routine programs through training.
• Participate in site audits and drive continuous improvement initiatives.

Skills

Dutch

English

Organizational skills

Technical writing

Education

Bachelor or Master in Industrial, Civil, Bio-engineering, Industrial Pharmacy or equivalent

Tools

PC software applications

Measurement technology

Job description

Our client, a prominent pharmaceutical organization, is seeking a professional to join their validation team. The role focuses on drafting protocols and defining sterilization approaches for various equipment projects in compliance with strict quality standards.

• Draft test protocols and reports for sterilization validation in accordance with cGMP and regulatory standards.
• Plan and monitor the practical implementation of validation tests for revalidations and requalifications.
• Investigate deviations or non-compliant results to identify root causes and suggest improvements.
• Maintain and update necessary GMP documentation throughout the project lifecycle.
• Coordinate activities within the team and communicate progress and deadlines to project stakeholders.
• Support the transfer of projects to routine programs through team training and development.
• Participate in site audits and contribute to continuous improvement initiatives for process optimization.

• Bachelor or Master in Industrial, Civil, or Bio-engineering, Industrial Pharmacy, or equivalent experience.
• You have 1+ years of experience in similar projects within a GMP environment.
• You possess proficiency in standard PC software applications and have a keen interest in measurement technology.
• You bring strong organizational skills and the capacity to work in an accurate and creative manner.
• You are fluent in Dutch and English with strong technical writing skills.

Nice to Haves

• Prior experience specifically within sterilization validation.
• Willingness to work in a shift system.