Biomanufacturing Associate

Title: Biomanufacturing Associate

Location: Walkersville, MD

Duration: 6 months assignment with extension up to 18 Months

Pay Range: $24/Hr. to $28/Hr. W2

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.

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.