Cleanroom Automation Technician

Fagron Sterile Services US (FSS); Wichita (KS); On-site; USD 48,000 - 70,000; Full time

Benefits offered by this job

Competitive salary

Benefits package

Job summary

Fagron Sterile Services US (FSS) in Wichita, KS, is seeking a Cleanroom Automation Technician to operate automated filling equipment with a focus on patient safety and quality. You will perform setup, teardown, cleaning, gowning, and document batch records while maintaining cGMP compliance.

The role requires attention to detail, ability to work with others, and initiative to prioritize tasks in a fast-paced, sterile manufacturing environment.

Qualifications

• High school diploma or equivalent is required.
• 1–4 years of experience in hospital, manufacturing production, or aseptic filling preferred.
• Experience with automated equipment or lines is preferred.
• Knowledge of cGMP regulations is preferred.
• Ability to aseptically gown and pass gowning qualifications.
• Strong attention to detail and focus on quality, sterility, and aseptic technique.

Responsibilities

• Operate and maintain automated filling equipment.
• Perform setup, teardown, and cleaning of automated equipment.
• Maintain cleanroom conditions, including gowning and sanitation and cGMP compliance.
• Ensure equipment validation activities are up to date.
• Assist in evaluating equipment performance and troubleshooting issues.
• Manage inventory of components for production batches.
• Coordinate with compounding/dispensing and aseptic/post-production teams.
• Document batch records, logs of equipment use/maintenance/cleaning, and logs.
• Maintain gowning standards semi-annually.
• Perform initial and routine equipment qualifications, including media fills when required.
• Follow SOPs and clock in/out for shifts.

Skills

Attention to detail

Aseptic technique

Team collaboration

Time management

Initiative

Adaptability

Organization

Education

High school diploma or equivalent

Tools

Automated equipment

Job description

Who We Are

Fagron was founded in Rotterdam (The Netherlands) in 1990 and is a dynamic organization with over 3,000 employees worldwide. As the global market leader in personalized medicine, we are highly passionate about being at the forefront of our field. Each day, we are committed to improving the lives of millions of people across the world by optimizing and innovating personalized pharmaceutical solutions.

About the Job

The Cleanroom Automation Technician will operate automated manufacturing equipment used to create products with a focus on patient safety and quality; they will ensure that equipment is operating appropriately to meet manufacturing demand.

Key Responsibilities

• Responsible for the operation and maintenance of automated filling equipment.
• Performs setup, teardown, and cleaning of automated equipment.
• Maintains cleanroom conditions, including gowning, sanitation, and adherence to cGMP procedures.
• Ensures that assigned equipment validation activities are up to date.
• Assists in assessing equipment performance and troubleshooting any challenges that arise.
• Manages inventory of components needed to fulfill production batches, as scheduled.
• Coordinates and communicates with compounding and dispensing to obtain supplies and with both aseptic and post-production teams.
• Documents batch records, lumacs (log use, maintenance, and cleaning of all equipment), and cleaning logs appropriately.
• Maintains gowning standards on a semi‑annual basis.
• Performs initial and routine qualifications for equipment, including media fills, if required.
• Follows standard operating procedures for completion of assigned tasks.
• Ticks clock in and out for each scheduled shift in a timely manner.

Basic Qualifications

• High school diploma or equivalent; one to four years of previous work experience in a hospital, manufacturing production environment, or aseptic filling.
• Experience with automated equipment or automated manufacturing lines preferred.
• Knowledge of and compliance with cGMP (Current Good Manufacturing Practices) regulations, preferred.
• Ability to aseptically gown and pass gowning qualifications.
• Ability to work with others in a positive, professional manner and to develop and maintain strong working relationships with co‑workers and management.
• Ability to take initiative, ask for and offer help when needed, and perform work independently without prompting.
• Strong attention to detail and focus on quality, accuracy, sterility, and aseptic technique.
• Ability to prioritize and plan work activities, manage time effectively, and adapt quickly to changing priorities.
• Ability to handle multiple tasks and organize resources to ensure work is completed on time.

What’s on Offer?

We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organizational culture, where individuals need strong motivation and the ability to work independently. Fagron is a widely expanding, international, professional, and ambitious pharmaceutical company with multiple growth opportunities. The job includes a competitive salary, comprehensive benefits, performance package, and the chance to be part of an international leader in an expanding industry.

Ready for the challenge?

Fagron North America is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race; creed; color; religion; national origin; sex; age; disability; sexual orientation; gender identity or expression; genetic predisposition or carrier status; veteran, marital, or citizenship status; or any other status protected by law.