Junior Sterilisation Validation Analyst

Pauwels Consulting; Puurs-Sint-Amands; On-site; EUR 42,000 - 62,000; Full time

Job summary

Pauwels Consulting is seeking a Validation professional to join the GMP-driven validation team in Belgium. You will draft sterilization validation protocols and oversee practical test implementation, ensuring compliance with cGMP and regulatory standards.

You will investigate deviations, maintain GMP documentation, and coordinate activities across the team while supporting transfers to routine programs and participating in site audits for continuous improvement.

Qualifications

• 1+ years of GMP project experience.
• Draft protocols and reports for sterilization validation.
• Plan and monitor validation tests for revalidations and requalifications.
• Investigate deviations and root causes; propose improvements.
• Maintain GMP documentation throughout project lifecycle.
• Coordinate team and communicate progress to stakeholders.
• Support transfer to routine programs through training.
• Participate in site audits and continuous improvement.

Responsibilities

• Draft test protocols for sterilization validation per cGMP and regulatory standards.
• Plan and monitor validation tests for revalidations and requalifications.
• Investigate deviations to identify root causes and improvements.
• Maintain GMP documentation across the project lifecycle.
• Coordinate activities and update stakeholders on progress and deadlines.
• Assist in transferring projects to routine programs via training.
• Contribute to site audits and process optimization initiatives.

Skills

GMP experience

Measurement technology interest

Strong organizational skills

Dutch language

English language

Education

Bachelor/Master in Engineering/Industrial Pharmacy

Tools

PC software proficiency

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.