Compliance Engineer Contamination Control

Job Description

As a Compliance Engineer Cross Contamination, you will take a central role in monitoring and strengthening the cross-contamination strategy within a pharmaceutical production environment in Geel. You will work closely with operations and various supporting departments to identify, assess, and mitigate contamination risks. In doing so, you will contribute directly to quality assurance, safe production processes, and continuous improvement.

Your responsibilities include:

• maintaining and reviewing risk assessments regarding cross contamination
• ensuring that contamination risks remain controlled during MOC activities
• preparing, guiding, and documenting cross contamination FMEA's
• providing support to operations during complex quality incidents and investigations
• identifying opportunities for improvement within contamination control processes
• collaborating with multidisciplinary teams within manufacturing, quality, and related departments
• contributing to the site-wide strategy for contamination control and compliance objectives
• applying your knowledge within an API production environment and correctly applying relevant GMP requirements

You communicate smoothly with diverse stakeholders and easily build strong working relationships. You approach issues in a structured manner and know how to align quality requirements with operational practice. You bring people together around a common goal and maintain an overview in an environment with various involved parties.

For this position, you bring the following:

• a bachelor's or master's degree in Chemical Engineering, Process Technology, Chemistry, Bio-engineering, or equivalent experience
• at least 3 years of experience in a pharmaceutical or industrial production environment
• knowledge of GMP, change management, FMEA, and methodologies for risk assessment and risk management
• insight into cross contamination risks and principles of contamination control
• knowledge of Annex 1 is a plus
• a smooth command of English, Dutch is a strong asset