Sterile Filling Technician I

STAQ Pharma, Inc.; Denver (CO); Vor Ort; USD 42.000 - 56.000; Vollzeit

Benefits dieser Stelle

Medical, dental, and vision insurance

401(k) retirement plan with employer

Paid time off (PTO), sick leave

7 paid holidays

Employee growth in a regulated pharma

Zusammenfassung

STAQ Pharma, Inc. is seeking a Sterile Filling Technician I to support aseptic filling operations in an ISO-7 cleanroom within a 503B facility. You will assist with setup, materials, equipment, labeling, and documentation while maintaining gowning standards and GMP compliance.

The role emphasizes attention to detail, teamwork, and adherence to safety and quality procedures, with a focus on patient safety and product integrity in a regulated environment.

Qualifikationen

• High school diploma or equivalent required.
• Experience in sterile manufacturing or cleanroom preferred.
• Basic arithmetic and documentation skills required.
• Ability to follow written and verbal instructions.

Aufgaben

• Support ISO-7 aseptic filling operations per SOPs and batch records.
• Prepare materials, equipment, and line readiness for sterile filling.
• Maintain gowning qualification and cleanroom behavior.
• Document work in real time and escalate deviations.
• Follow GDP/cGMP requirements and safety procedures.

Kenntnisse

Attention to detail

Teamwork

Clear communication

English proficiency

Ausbildung

High school diploma or equivalent

Jobbeschreibung

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.

What This Role Does Day-to-Day

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.

Key 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 elevate 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.

What Success Looks Like

• 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.

Required 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 elevate 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.

Work Environment

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 safety and regulatory procedures.

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

At STAQ Pharma, all full time employees have access to:

The application window for this position is anticipated to be open at least 25 days

Working hours are Tuesday - Friday, 3:00pm - 1:30am.