• Develop and execute process validation protocols and reports in accordance with regulatory requirements and industry best practices.
• Perform risk assessments and gap analyses to identify areas for process improvement and ensure the reliability of manufacturing processes.
• Collaborate cross-functionally with manufacturing, quality assurance, regulatory affairs, and other departments to support process validation activities.
• Lead and/or participate in investigations related to process deviations, non-conformances, and CAPAs, and implement corrective and preventive actions as needed.
• Support technology transfer activities between development and manufacturing sites, ensuring successful scale-up and transfer of processes.
• Stay current with industry trends, regulatory requirements, and best practices related to process validation and contribute to the continuous improvement of validation processes and procedures.

Requirements:

• Bachelor's or master's degree in engineering, Pharmaceutical Sciences, or related field.
• Minimum of 3 years of experience in process validation within the pharmaceutical or biotechnology industry.
• Strong understanding of regulatory requirements (e.g., FDA, EMA, ICH) related to process validation.
• Experience with risk assessment methodologies (e.g., FMEA) and statistical analysis tools (e.g., Minitab) is preferred.