We are seeking a highly skilled Manufacturing Operations Specialist to join our team. This key role will provide technical support for new product introduction and commercial manufacturing, collaborating with cross-functional teams and liaising with external partners.
About the Role:
* Develop and execute qualification/validation documentation and process development studies, ensuring compliance with regulatory requirements and industry best practices.
* Contribute to continuous improvement initiatives, providing technical input into quality notifications and process enhancements.
* Manage equipment/qualification validation programs, performing root cause analysis of system failures and implementing corrective actions.
* Promote adherence to Global Policies, Procedures, and Guidelines, regulatory requirements, and current Good Manufacturing Practices (cGMP).
The ideal candidate will possess a Bachelor's degree or higher in a Science, Engineering, or Technical discipline, with at least 3 years of experience in manufacturing, preferably in a GMP setting. Knowledge of process monitoring systems, automation systems, operational intelligence & data systems, and regulatory/code requirements is desirable.
This position offers a unique opportunity to work in a dynamic environment, driving innovation and excellence in manufacturing operations. If you are a motivated professional with a passion for delivering results, we encourage you to apply.