Manufacturing Associate Level 1

Job Summary Responsible for performing production functions in a powder or liquid media manufacturing facility according to company and departmental Standard Operating Procedures (SOPs). Maintains accurate records in compliance with Good Manufacturing Practices (GMP) and works in a fast-paced, safety-oriented, team environment. This role primarily supports aseptic liquid filling operations, including manual and automated filling of bottles and bags in a cleanroom manufacturing environment. Responsible for performing production functions in a powder or liquid media manufacturing facility according to company and departmental Standard Operating Procedures (SOPs). Maintains accurate records in compliance with Good Manufacturing Practices (GMP) and works in a fast-paced, safety-oriented, team environment. This role primarily supports aseptic liquid filling operations, including manual and automated filling of bottles and bags in a cleanroom manufacturing environment. 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. Perform other duties as assigned. Qualifications Required 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. Schedule Monday through Thursday, 6:30 AM - 5:00 PM. Employees are expected to arrive by 6:30 AM for the daily production briefing before gowning into the cleanroom. Occasional early start times and overtime may be required based on production needs, with advance notice provided whenever possible. #J-18808-Ljbffr Lenmar Consulting Inc