Sterile Filling Technician I

About the role

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.

Responsibilities

• 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.
• Absorb and 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, documentation concerns, product concerns, process concerns, or any situation that may impact safety, quality, or compliance.
• Stop work and notify appropriate personnel if a task may present an imminent safety, quality, or compliance risk.
• Obtain clarification and guidance from leadership before proceeding when unsure how to complete a task, document a step, or respond to an issue.

Qualifications

• 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.

Physical Requirements

• 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.

Benefits

• Medical, dental, and vision insurance options.
• Employer-paid life insurance and disability coverage.
• Employee Assistance Program.
• 401(k) retirement plan with employer match.
• Paid time off (PTO), sick leave.
• 7 paid holidays.
• Opportunities for professional growth in a regulated pharmaceutical manufacturing environment.
• Employee-focused culture emphasizing safety, quality, and teamwork.