Cleanroom Sterile Services Technician

Fagron Sterile Services US (FSS); Wichita (KS); On-site; USD 38,000 - 46,000; Full time

Benefits offered by this job

Competitive salaries

401(k) plan with company matching

Medical, Vision & Dental

Health savings account (HSA)

Holiday/paid time off

Job summary

Fagron Sterile Services US (FSS) seeks a dedicated production professional to prepare and compound sterile medications in a cleanroom, ensuring CGMP compliance and precise documentation.

The role involves maintaining a sterile environment, preparing vials and components, verifying prescriptions, and aiding in batch tracking while working closely with the team to uphold patient safety and product quality.

Qualifications

• Experience in a production or cleanroom environment.
• Ability to follow CGMP regulations and SOPs.
• Excellent attention to detail with strong documentation skills.
• Ability to lift up to 60 lbs and work in a fast-paced setting.

Responsibilities

• Prepare the clean room with materials and prescriptions to GMP standards.
• Maintain sterile environment by garbing and cleaning per procedures.
• Sterilize components and fill into specified containers.
• Prepare and verify individual compounds according to schedule and GMP.
• Check prescriptions, labels, and dosages for accuracy.
• Clean equipment and workspace; monitor for residual materials per quality guidelines.
• Follow safety guidelines to prevent accidents during production orders.
• Log shift times accurately and complete required documentation.
• Perform other duties as assigned.

Skills

Cleanroom experience

Aseptic technique

GMP compliance

Teamwork

Attention to detail

Documentation

Physical stamina

Communication

Education

High school diploma or equivalent

Job description

Since 1990, weve grown into a global leader in personalized medicine.

Today, our +5,000 energetic employees are based in +80 locations in Europe, North America, South America, Africa and Asia-Pacificand are working together to support over 200,000 customers worldwide.

From compounding and natural products to software, equipment, and genomics we deliver smart, ready-to-use solutions that make healthcare better.

We're passionate, science-driven, and always looking for new ways to improve lives.

Explore your future at Fagron Career Site.

About The Job

Responsible for preparing and compounding sterile pharmaceutical medications in a cleanroom environment while followingGMP, SOP, quality, and safety requirements. Duties include cleanroom preparation and maintenance, sterilization and autoclaving, vial and equipment preparation, prescription and label verification, batch and lot tracking, accurate documentation, and maintaining proper FIFO rotation. The role requires strong attention to detail, teamwork, organization, and a commitment to patient safety and product quality.

Key Responsibilities

• Prepare the clean room (materials, resources, prescriptions, etc.) with the aim of eliminating any errors and to work according to Good Manufacturing Practices.
• Maintains a sterile environment in the clean room, by garbing, cleaning the room, and behaving according to clean room procedures that align with CGMP practices or guidelines.
• Prepares and sterilizes components/vials for appropriate solutions; sterilizes solutions and fills into specified containers.
• Prepare individual pharmaceutical compounds according to schedule and prescribed medication as well as GMP requirements, with the aim of providing the patient with the correct medication.
• Check prescriptions and compound preparations (personal details, dosing, validity date, etc.) and label and send the medication out, with the aim of ensuring that the patient is provided with the correct medication.
• According to defined guidelines, clean the equipment and the workplace as well as monitor possible residual materials with the aim of working in a neat and clean environment which adheres to the quality guidelines so as to prevent accidents and incidents.
• Show respect for the quality, neatness and safety guidelines when carrying out production orders with the aim of preventing accidents and other unwanted incidents.
• Clock in and out for every scheduled shift in a timely manner.
• Other duties as assigned.
• Collection of vials out of cleanroom pass throughs, ensuring stoppers are set flush in vials per SOP.
• Labels are placed on trays, label and Lot control.
• Working within the team on first in and first out rotation of crimping.
• Tracking batches within Felton per SOP.
• Equipment prep and maintenance.
• Autoclaving and ensuring proper sterilization occurred on batches.

Required

• Proper documentation

Basic Qualifications

• Experience working in a production environment, ideally in a cleanroom setting.
• Ability to effectively communicate with others.
• Ability to lift up to 60 lbs.
• High school diploma or equivalent; one to four years previous work experience in a hospital or manufacturing environment or doing aseptic filling.
• Knowledge of clean room procedures, preferred but not required.
• Knowledge of and compliance with CGMP (Current Good Manufacturing Practices) Regulations, Preferred But Not Required.
• Ability to take initiative, including asking for and offering help when needed; performs work independently without being prompted.
• Ability to prioritize and plan work activities. Manages time effectively and adapts quickly to changing priorities.
• Ability to work within tight timelines.
• Ability to handle multiple tasks and organize resources to ensure work is completed on time.
• Strong attention to detail and focus on quality, accuracy, sterility, and aseptic technique.
• Basic computer and math skills.
• Positive attitude and the ability to work in a team environment.

What's on Offer?

• Competitive salaries
• 401(k) plan with a company matching contribution
• Medical, vision and dental
• Health savings account (HSA)
• Holiday/paid time off

At Fagron, youll find plenty of chances to grow both personally