Job 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 environment. 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 efficient 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 Good 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 autoclave activities comply with applicable regulatory requirements including FDA, EMA, and internal quality guidelines
• Monitor autoclave cycle parameters, temperature, pressure, and time to ensure validated sterilization conditions are met
• Participate in functional team projects focused on developing process improvement methods, solutions, and procedures to enhance quality and scheduling

Additional Responsibilities:

Education:

• B. Pharm B. Pharm - Required
• M. Pharm M. Pharm - Preferred

Experience:

• 1 year or more in 1 - 4 Years

Specialized Knowledge: Licenses:

Amneal is an equal opportunity employer. We do not discriminate based on caste, religion, gender, disability, or any other legally protected status. We believe in fostering a workplace that values diversity and inclusion.