Manufacturing Associate Level 1

Lenmar Consulting Inc; Walkersville (MD); On-site; USD 36,000 - 56,000; Full time

Job summary

Lenmar Consulting Inc in Maryland is seeking a Production Operator to support aseptic liquid filling in a GMP-cleanroom environment. You will perform manual and automated filling of bottles and bags, set up production and filling equipment, and document manufacturing activities in real time.

The role requires a High School Diploma or GED (Bachelor’s preferred), 0–4 years of manufacturing experience, ability to lift up to 40 pounds, strong attention to GMP/SOPs, and good teamwork in a fast-paced

Qualifications

• 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.
• GMP, SOPs, and manufacturing documentation experience.

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 environment while adhering to gowning 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.

Skills

GMP knowledge

SOP knowledge

Cleanroom operations

Equipment operation

Documentation & batch records

Attention to detail

Team collaboration

English fluency

Education

High School Diploma or GED

Bachelor's degree in Science/Engineering (preferred)

Tools

Laminar Flow Biological Safety Cabinet (LFBSC)

Autoclave

Fill-finish equipment

Job description

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.