Description
Description:
This role is responsible for performing a variety of tasks related to the operation and maintenance of autoclave equipment within a regulated pharmaceutical manufacturing workplace. The role operates autoclave systems to ensure all manufacturing equipment, materials, and products are properly sterilized in compliance with pharmaceutical quality standards. The role handles equipment and materials in compliance with stringent quality and safety standards. It involves executing standard operating procedures to meet current Good Manufacturing Practices and maintaining accurate records as required by regulatory bodies. The position ensures all tasks are completed in full compliance with applicable regulatory requirements including FDA and EMA guidelines. The role contributes to process improvement initiatives by participating in functional team projects aimed at enhancing quality, cost efficiency, and scheduling effectiveness.
It supports the optimization of resource utilization while minimizing costs and maintaining the highest quality standards in pharmaceutical manufacturing. The role plays a key role in sustaining a compliant and productive autoclave operation within a global pharmaceutical organization.
Essential Functions:
Operate autoclave equipment to sterilize manufacturing materials, equipment, and products in accordance with approved procedures and validated cycles
Handle manufacturing equipment and materials with appropriate care and documentation to ensure sterility and compliance
Execute standard operating procedures to ensure compliance with current Positive Manufacturing Practices for autoclave operations
Maintain accurate sterilization records, batch documentation, and autoclave logs as required by regulatory and quality standards
Perform general maintenance tasks on autoclave equipment and related machinery as needed
Conduct area cleaning and sanitization activities to maintain manufacturing area standards
Ensure all