Sterile Filling Technician I

STAQ Pharma Inc • Denver, CO

21h • $0 - $28 • Onsite

About The Position

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.

Position Summary

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.

Requirements

• 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.

Nice To Haves

• 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.
• Basic chemistry or filling-related calculations preferred.

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.
• 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.
• Maintain a quality-focused, Right First Time mindset and understand the team’s direct impact on product quality and patient safety.
• Communicate effectively across shifts and with cross-functional partners, including Production, Quality, and leadership.
• Support continuous improvement by speaking up when there may be a safer, more compliant, or more efficient way to perform a task.
• Perform other duties as assigned based on business and production 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

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED