What are the responsibilities and job description for the Industrial Process Development Expert position at cyberThink Inc?
About the Opportunity
CyberThink Inc offers a challenging opportunity for a skilled Senior Quality and Validation Manager to join our team.
The successful candidate will lead 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.
