Process Expert

Key Responsibilities:

• Act as Subject Matter Expert for assigned products and manufacturing processes, ensuring reliable and compliant execution.
• Provide technical support to ensure timely process execution and maintain business continuity in manufacturing.
• Collaborate on process deviations and support investigations to identify root causes and implement corrective actions.
• Manage process changes through formal change control procedures, ensuring full compliance with regulatory requirements.
• Support validation strategies, qualification activities, and ongoing process verification to ensure consistent product quality.
• Prepare for and support internal and external inspections, ensuring readiness and adherence to regulatory expectations.
• Analyze process performance trends and contribute to continuous improvement, innovation, and product quality reviews.
• Lead or support operational excellence initiatives, driving productivity improvements, data utilization, and process optimization.

Essential Requirements:

• University degree in a scientific or engineering field such as pharmacy, chemical engineering, engineering or pharmaceutical technology.
• Minimum two years of experience supporting manufacturing processes.
• Strong understanding of manufacturing processes and ability to quickly learn complex production technologies.
• Knowledge of quality standards and regulatory requirements within pharmaceutical manufacturing.
• Experience working with manufacturing execution systems and enterprise resource planning systems.
• Strong communication and collaboration skills, with the ability to influence stakeholders across different functions.

Desirable Requirements:

• Experience in manufacturing in a regulated pharmaceutical environment.