1st Shift Production Sterilization Specialist

Job Summary

The Production Sterilization Specialist will be responsible for conducting labeling, packaging, and production support activities to support commercial manufacturing. Under the direction of the Production Supervisor/Team Leader, the Production Support Associate will work hands-on under ISO7, ISO8, and other classified areas with various manufacturing production equipment and technologies. Daily responsibilities vary, including operating cleaning machines and preparing supplies for manufacturing by cleaning and disinfecting. 

Core Responsibilities

• Ensures that all work is carried out in compliance with company Safety Policies, current Good Manufacturing Practices (cGMP), and Standard Operating Procedures (SOPs).
• Wears proper personal protective equipment and follows aseptic procedures when gowning, de-gowning, and working in sterile and controlled areas.
• Reports any accidents, incidents, injuries, or illnesses immediately and notifies the manager of any workplace hazards, unsafe acts, or conditions.
• Accurate completion of product documentation and all appropriate logbooks. Maintains cleaning logs per SOP requirements.
• Knowledge of current Good Manufacturing Practices (cGMP) guidelines.
• Excellent organization and time-management skills are required. Must promptly manage a heavy workload and aggressive timelines, prioritize, and work under pressure.
• Cleaning, sanitizing, and disinfection of equipment and components required for production. 
• Works with the Warehouse Department to ensure all components are available ahead of time for production. 
• Completes all necessary cleaning and sanitizing of production equipment and area.
• Stages material for production use.
• Operation of cleaning equipment including but not limited to Autoclave, Fedegari, and Depyrogentation oven.
• Performs calibration of check weighing.

Qualifications & Requirements

• High School Diploma or equivalent work and education in a related field are required.
• 1-3 years of experience working in the pharmaceutical industry and within aseptic clean room environments.
• Demonstrated ability to successfully gown into aseptic manufacturing areas.
• Ability to handle sensitive information with a high degree of confidentiality.
• Ability to work in a fast-paced environment while demonstrating excellent time management and organization skills.
• Proficient in using standard Microsoft Office software products, including Excel, Outlook, and Word.
• Strong organizational skills with the proven ability to prioritize.
• Works with a sense of urgency while engaging and listening to experts.

 Position Type 

• On-Site

Travel

• None