Sterilization Validation Specialist

Pauwels Consulting

Puurs-Sint-Amands

On-site

EUR 45,000 - 65,000

Full time

2 days ago

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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.