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.

The Sterile Filling Technician I is a member of the Production Team responsible for supporting aseptic filling operations required to manufacture sterile pharmaceutical products in a 503B outsourcing facility. This role primarily works in a classified ISO-7 cleanroom environment and requires employees to follow detailed procedures, maintain gowning qualification, wear appropriate PPE, complete documentation accurately, and maintain a strong focus on patient safety and product quality.

This position supports sterile filling by assisting with setup, staging, classified area support, equipment and material preparation, documentation, cleaning, restocking, visual inspection, labeling, and other production support activities as assigned. The Sterile Filling Technician I plays an important role in helping ensure sterile products are produced in accordance with cGMP, GDP, company procedures, and applicable regulatory requirements.

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.

• Perform ISO-7 support functions for aseptic filling operations according to approved protocols, SOPs, batch records, work instructions, and cGMP requirements.

• Support sterile filling activities, including material preparation, staging, equipment support, line support, in-process assistance, and production-related tasks as assigned.

• Acquire and maintain classified area gowning qualification and consistently follow cleanroom behavior, PPE, and contamination control expectations.

• Learn and use relevant filling equipment, tools, systems, and technology according to established procedures and work instructions.

• Complete required training and maintain qualifications for assigned sterile filling and production support tasks.

• Accurately and contemporaneously document work according to GDP expectations, including batch record entries, logs, checklists, and other required production records.

• Assist with classified and non-classified area cleaning, sanitization, organization, restocking, and readiness activities as required.

• Perform visual inspection, labeling, and other production support tasks when required or assigned.

• Safely handle materials, components, chemicals, solvents, corrosives, pharmaceutical compounds, and other production supplies as required.

• Identify and escalate potential deviations, equipment issues,…