Develop, pilot, and deploy a cross-contamination risk assessment framework with a multidisciplinary team
Design and implement a governance process to ensure risk assessments remain current during changes (MoC) and are reviewed periodically
Facilitate and document initial FMEAs related to cross-contamination
Support complex quality incident investigations and improvement initiatives
Collaborate effectively with various internal stakeholders across departments
Qualifications & Experience:
Bachelor's or Master's degree in Chemical Engineering, Process Technology, Industrial Engineering, Bioengineering, or Chemistry - or equivalent professional experience in an industrial/operational environment
Solid understanding of quality compliance, change management, and risk assessment methodologies in a pharmaceutical setting
Preferred experience in cross-contamination control strategies
Knowledge of contamination control principles and relevant regulatory standards (e.g., EU Annex 1)
Familiarity with equipment such as batch chemical reactors, spray dryers, dryers, and centrifuges is highly valued
