Filling Technician; pharma​/biotech

Overview

Filling Technician (Aseptic Manufacturing) —

Location:

Onsite.

Schedule:

Monday–Friday | 8:30 AM – 5:00 PM. Pay Rate: $27–$30/hour.

Terms:

5 month contract-to-hire.

We are seeking an experienced Filling Technician to support the manufacturing of biotechnology products intended for clinical and commercial human use. This role operates in controlled cleanroom environments and requires strong experience in aseptic processing and sterile filling operations. The ideal candidate will be comfortable working in ISO-classified clean rooms, performing aseptic gowning procedures, and following FDA cGMP regulations and SOPs to ensure product quality, compliance, and production efficiency.

This position is part of a small, collaborative team of six technicians and offers long-term growth opportunities within the organization.

• Aseptic Manufacturing Operations:
  Perform aseptic filling operations for sterile biotechnology products.
• Operate and set up filling equipment including syringe fillers, peristaltic pumps, and filtration systems.
• Conduct line clearance and line inspections for ISO 5–8 cleanroom environments.
• Perform drug product formulation and sterile filtration activities.
• Prepare media, buffers, and disinfectant solutions as required.
• Execute media fill activities to verify aseptic process performance.

• Operate manufacturing equipment such as autoclaves, part washers, mixing systems, and filtration units.
• Calibrate and verify equipment including pH meters, conductivity meters, and weighing scales.
• Perform filter integrity testing and monitor particle counts.
• Troubleshoot equipment and manufacturing process issues.

• Maintain and sanitize ISO5 and ISO6 areas according to SOPs.
• Follow routine cleanroom cleaning and sanitation schedules.
• Conduct environmental monitoring and in-process testing, including personnel monitoring plates.

• Complete batch records, logbooks, and electronic documentation accurately and in a timely manner.
• Ensure compliance with FDA cGMP, SOPs, and company policies.
• Review and update manufacturing documentation, SOPs, and forms as needed.
• Participate in process investigations, CAPA implementation, and validation/qualification activities.

• Work closely with cross-functional teams to support technology transfer from process development to manufacturing.
• Communicate processing timelines with internal stakeholders.
• Identify opportunities to improve efficiency, reduce waste, and optimize production processes.

• Bachelor’s degree in a scientific field preferred (required for long-term career growth within the organization)
• 3+ years of aseptic manufacturing or sterile filling experience
• Experience working in cleanroom environments (ISO-classified areas)
• Strong understanding of cGMP regulations and pharmaceutical manufacturing processes
• Experience with aseptic techniques and sterile processing

• Knowledge of biotechnology manufacturing processes, including:
  • Aseptic filtration systems
  • Aseptic sampling
  • Filter integrity testing
  • Peristaltic pumps and mixing systems
• Experience with manufacturing systems such as POMS, LIMS, SAP, or Net Suite
• Ability to work with Word, Excel, and data tracking systems

• GMP / GLP regulations
• ISO cleanroom classifications
• ALCOA+ data integrity principles (Attributable, Legible, Contemporaneous, Original, Accurate + additional data integrity controls)
• Media Fill processes and their role in validating aseptic manufacturing

• Strong attention to detail and documentation accuracy
• Ability to follow complex procedures and technical instructions
• Effective communication and teamwork skills
• Ability to troubleshoot equipment and process issues with minimal supervision