Cleanroom Automation Technician - 3rd Shift

Fagron Tech; Wichita (KS); On-site; USD 40,000 - 60,000; Full time

Benefits offered by this job

Competitive salary

Comprehensive benefits

Performance package

Job summary

Fagron North America seeks a Cleanroom Automation Technician to operate and maintain automated filling equipment, ensuring sterile, compliant production and accurate batch records.

You will perform setup, teardown, cleaning, gowning, and routine equipment qualifications while collaborating with aseptic and post-production teams; a high school diploma and 1–4 years in manufacturing or hospital settings are required.

Qualifications

• High school diploma or equivalent; 1–4 years in hospital, manufacturing, or aseptic filling.
• Experience with automated equipment or automated manufacturing lines preferred.
• Knowledge of cGMP regulations; gowning qualifications preferred.
• Ability to work with others in a positive and professional manner and to develop strong working relationships.
• Ability to take initiative and work independently when needed; attention to detail is critical.

Responsibilities

• Operate and maintain automated filling equipment.
• Perform setup, teardown, and cleaning of automated equipment.
• Maintain cleanroom conditions, gowning, sanitation and cGMP compliance.
• Ensure equipment validations are up to date.
• Assist in troubleshooting and performance assessment of equipment.
• Take inventory to identify components for production batches.
• Coordinate with compounding and dispensing teams for supplies; communicate with aseptic and post-production teams.
• Document batch records and log usage, maintenance, and cleaning of equipment.
• Perform initial and routine equipment qualifications, including media fills if required.

Education

High school diploma or equivalent

Job description

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, by gowning, sanitation, and behaving according to procedures that align with cGMP practices or guidelines.
• Ensures that assigned equipment validation activities are up to date.
• Help assess performance of equipment and aid in trouble shooting for any challenges that arise.
• Takes inventory to identify components needed to fulfil production batches, as scheduled.
• Coordinates and communicates with compounding and dispensing to obtain supplies needed to turn products; communicates with both the aseptic and post-production teams.
• Document batch records, lumacs (log use, maintenance, and cleaning of all equipment), and cleaning logs appropriately.
• Ensures that gowning standards have been maintained on a semi-annual basis.
• Performs initial and routine qualifications for equipment, including media fills, if required.
• Follows standard operation procedures for the completion of assigned tasks.
• Clock in and out for each scheduled shift in a timely manner.

Basic Qualifications

• High school diploma or equivalent; one to four years 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 and professional manager and to develop and maintain strong working relationship with co-workers and management.
• Ability to take initiative, including asking for and offering help when needed; performs work independently without being prompted.
• Strong attention to detail and focus on quality, accuracy, sterility, and aseptic technique.
• Ability to prioritize and plan work activities. Manages time effectively and adapts quickly to changing priorities.
• Ability to handle multiple tasks and organize resources to ensure work is completed on time.

Benefits

• Competitive salary, comprehensive benefits, performance package.

Equal Opportunity Employer

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.