Sterile Filling Technician

Sterile Filling Technician I

The Sterile Filling Technician I supports aseptic filling operations in a classified ISO-7 environment within a 503B pharmaceutical manufacturing facility. This role assists with sterile filling activities, equipment and material preparation, classified area support, documentation, cleaning, restocking, visual inspection, labeling, and other production support tasks as assigned.

This position requires strong attention to detail, strict adherence to cGMP/GDP, cleanroom behavior, PPE and gowning expectations, and the ability to follow batch records, SOPs, and work instructions exactly. The Sterile Filling Technician I contributes directly to product quality and patient safety by supporting sterile operations in a controlled and compliant manner.

This is a strong opportunity for someone who is dependable, detail-oriented, comfortable working in a regulated cleanroom environment, and motivated to build a career in sterile pharmaceutical manufacturing.

In this role, the Sterile Filling Technician I may support sterile filling operations through material staging, equipment preparation, line support, classified area cleaning, restocking, documentation, inspection, and labeling activities. Daily responsibilities may include preparing the work area, following batch records and work instructions, assisting with fill-related production tasks, documenting work in real time, and escalating anything that does not match the defined process.

The role requires careful, consistent work in an ISO-7 classified environment, including during repetitive or highly detailed tasks. Candidates should be comfortable wearing PPE for most of the shift, following gowning and cleanroom behavior expectations, adapting to changing production priorities, and communicating with leads, supervisors, Quality, and other team members when questions or concerns arise.

Arrives on time and is prepared to work in the assigned classified environment at the start of the shift. Follows SOPs, batch records, gowning requirements, cleanroom expectations, and work instructions exactly without taking shortcuts. Maintains focus and accuracy during repetitive filling support, cleaning, inspection, labeling, or documentation activities. Completes documentation accurately, legibly, and in real time according to GDP/cGMP expectations. Speaks up when something does not look right and escalates questions, deviations, documentation concerns, or equipment issues before proceeding.

Works well with others, communicates clearly across shifts and departments, and accepts feedback professionally. Demonstrates accountability, integrity, reliability, and a willingness to learn multiple sterile manufacturing processes. Understands that sterile filling activities directly impact product quality, compliance, and patient safety.

High school diploma or equivalent required. Prior sterile compounding, aseptic processing, pharmaceutical manufacturing, medical device, cleanroom, regulated manufacturing, production, packaging, inspection, or quality-focused experience preferred. Prior experience operating manufacturing equipment or machinery preferred. Knowledge of cGMP, GDP, FDA-regulated environments, cleanroom expectations, sterile compounding, or aseptic manufacturing concepts preferred. Must be able to speak, read, and write in English. Must pass required drug screening and any required vision or qualification screening.

Must have excellent attention to detail and ability to follow written instructions. Must be comfortable working in a fast-paced environment with changing priorities and production demands. Must be willing to participate in training, maintain gowning and job-task qualifications, and gain additional certifications as required. Basic arithmetic and measurement skills required; basic chemistry or filling-related calculations preferred. Must demonstrate teamwork, accountability, integrity, clear communication, and willingness to escalate concerns.

Ability to work in a classified ISO-7 environment while wearing required PPE for most or all of the shift. Ability to stand, sit, walk, bend, reach, and perform repetitive tasks for extended periods. Ability to lift up to 50 pounds at times and push, pull, move, or handle materials, product containers, pallets, or equipment as needed. Ability to perform detailed work while maintaining focus, accuracy, and cleanroom discipline.

Ability to work variable shifts, overtime, weekends, or multi-shift schedules based on business needs.

This position primarily works in a classified ISO-7 cleanroom environment within a 503B pharmaceutical manufacturing facility. Employees are expected to follow gowning, PPE, cleanroom behavior, contamination control, safety, documentation, and conduct expectations at all times. The role may involve exposure to chemicals, solvents, corrosives, pharmaceutical compounds, sterile production materials, and manufacturing equipment, all of which must be handled according to approved…