Abstract: The integration of Industry 4.0 technologies within the pharmaceutical manufacturing sector aligns with broader industrial objectives, aiming to enhance productivity and adaptability while meeting challenging standards for product quality and diversity while maximizing efficiency. However, this shift is not risk-free. This particularly concerns the well-being of workers which is one of the top concerns shared by manufacturers. As the industry navigates this transition, it is imperative to prioritize the safety of personnel. The rapid pace of technological innovation within pharmaceutical manufacturing carries significant implications, introducing new and emerging risks. Consequently, proactive identification and assessment of these potential threats are essential to effectively mitigate their impact and ensure preparedness for forthcoming changes. To address this gap, this study provides an approach for identifying potential sources and significant factors contributing to its increasing risks in implementing Industry 4.0 in manufacturing industries. This set of sources and factors was evaluated in a medium-sized pharmaceutical manufacturing company aided by TICHNER and HIRAC Tools through a mixed-method approach. The combination of these tools facilitates the identification, characterization, and analysis of new and emerging risks associated with Industry 4.0 implementation. The findings of the study showed that Psychosocial Hazards and Work Experience/ Knowledge are the most common potential sources of Psychological Risks, Unemployment, and Need for Qualified Workers. The approach will allow manufacturers to proactively manage the new and emerging challenges brought by Industry 4.0 and safeguard the well-being of the workforce.
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