Compliance Engineer Contamination Control

Job Description

Your role as Compliance Engineer Cross Contamination

Are you interested in combining quality compliance with technical risk management in a pharmaceutical production environment? As a Compliance Engineer Cross Contamination, you will play an important role in maintaining and strengthening the cross-contamination strategy at an API production site in Geel. You will work closely with operations and various departments to identify, assess, and mitigate contamination risks. With your expertise, you will contribute to sustainable compliance and safe production processes. This is a visible role with a direct impact on quality, operational excellence, and continuous improvement.

Your responsibilities

• Identify, analyze, and mitigate cross-contamination risks within the production environment.
• Collaborate with operations and other internal stakeholders to support a sustainable contamination control strategy.
• Apply GMP guidelines and quality requirements within an API production environment.
• Support change management processes, including MOC, in terms of compliance and risk management.
• Perform and guide risk assessments using methodologies such as FMEA and other relevant risk assessments.
• Contribute to safe processes, quality assurance, and continuous improvement.
• Bachelor's or Master's degree in Chemical Engineering, Process Technology, Chemistry, Bio-engineering, or equivalent through experience.
• At least 3 years of experience in a pharmaceutical or industrial production environment.
• Knowledge of GMP, change management, MOC, FMEA, and risk assessment methodologies.
• Insight into cross-contamination risks and principles of contamination control.
• Knowledge of Annex 1 is a plus.
• You communicate smoothly with various stakeholders and build strong working relationships.
• You work in a structured manner and know how to balance quality requirements with operational reality.
• You bring people together around a common goal and coordinate activities effectively.
• You speak fluent English; knowledge of Dutch is a strong asset.