What are the responsibilities and job description for the Process Excellence Manager - Manufacturing position at cyberThink Inc?
About the Job
CyberThink Inc seeks an experienced Senior Quality and Validation Manager to drive industrial process excellence and guarantee the accuracy, conformity, and competitiveness of vaccine and biologic production.
This role involves leading the development and implementation of robust processes, testing strategies, and associated know-how transfer to ensure accuracy, conformity, and competitiveness of vaccine and biologic production.
- Develop and execute process validation plans, reports, and procedures to support adjuvant manufacturing activities.
- Lead the execution of development and validation related studies.
- Document and interpret study results with recommendations to stakeholders.
- Provide technical leadership as a subject matter expert in multiple areas of responsibility.
- Develop and execute training programs for appropriate audiences.
- Ensure compliance with cGMP, internal, and external quality and regulatory guidance, and health and safety guidelines.
- Leverage project team leadership skills within area of expertise.
- Assess existing processes and workflows to identify opportunities for improvement.
- Translate processes to commercial operations effectively.
- Own equipment unit operations and technology capabilities.
- Communicate findings and proposals to upper management.
- Enhance Manufacturing Technology strategic programs by addressing non-conformance issues related to change controls, deviations, CAPAs.
- Participate in Gemba/shop floor walk-throughs to learn about production processes and/or interview stakeholders to collect data for continuous improvement of strategic programs and development of validation strategies/documents.
