Role Summary
We are seeking a skilled technician with expertise in aseptic or cleanroom environments to manage various responsibilities. This role involves handling all manufacturing tasks for new product introductions and clinical manufacturing of small and large molecules.
* Develop and implement processes to ensure efficient batch preparation and area preparation.
* Collaborate with vendors to optimize system performance and improve workflows.
* Perform complex operations such as compounding, filtration, and filling.
* Ensure compliance with Good Manufacturing Practices (GMP) and Standard Operating Procedures (SOPs).
Key Responsibilities
* Prepare components and equipment for Grade A environments.
* Operate multi-product suites, ensuring smooth campaign switching.
* Conduct environmental monitoring and testing.
Requirements
* Relevant qualification or 18-24 months' experience in the pharma/med device industry.
* Mandatory knowledge of aseptic practices in clean rooms.
* Desirable: Strong knowledge of GMP, quality systems, drug manufacturing, and validation principles.