Manufacturing Associate Level 1

Responsibilities

• Execute aseptic processing in a cleanroom environment following SOPs.
• Perform manual and automated aseptic liquid filling of bottles (0.2 mL to 1 L) and bags (1 L to 20 L), including capping operations.
• Set up and operate production and filling equipment.
• Complete manufacturing documentation concurrently with manufacturing activities in compliance with GMP requirements.
• Perform personal and environmental monitoring.
• Gown aseptically and work in a cleanroom manufacturing environment while adhering to gowning and contamination control procedures.
• Clean production tanks, filling equipment, and associated manufacturing equipment.
• Prepare bulk formulations and stock solutions.
• Process production batches using a Laminar Flow Biological Safety Cabinet (LFBSC).
• Perform integrity testing on sterilizing filters.
• Wrap and assemble filling materials for autoclaving.
• Perform material transfer activities, including de-boxing, disinfecting cleanroom materials, and staging.
• Assist with drum filling operations as required.
• Complete assigned departmental tasks, including cleaning, lab setup, and maintaining an organized work area.
• Maintain equipment and facility cleanliness in accordance with GMP and cleanroom standards.
• Review and sign manufacturing batch records and related documentation.
• Maintain accurate production inventory.
• Provide information related to deviations to support investigations.
• Maintain required job training.
• Be available to work overtime or adjusted start times as business needs require.

Qualifications

• High School Diploma or GED required; Bachelor's degree in Science, Engineering, or a related field preferred.
• 0-4 years of manufacturing experience.
• Experience working in a cleanroom or aseptic manufacturing environment.
• Experience with aseptic filling, fill-finish operations, or sterile manufacturing preferred.
• Knowledge of Good Manufacturing Practices (GMP), Standard Operating Procedures (SOPs), and manufacturing documentation.
• Ability to accurately complete GMP documentation and batch records.
• Strong manufacturing and technical skills.
• Comfortable performing basic arithmetic required for production calculations.
• Ability to operate production and filling equipment.
• Ability to lift up to 40 pounds.
• Ability to gown and work for extended periods in a cleanroom manufacturing environment.
• Ability to work in a fast-paced, team-oriented environment.
• Business fluent in English.