Cleanroom Specialist

Fagron Sterile Services US (FSS); Wichita (KS); On-site; USD 55,000 - 75,000; Full time

Benefits offered by this job

Competitive salary

Comprehensive benefits

Job summary

Fagron US is seeking a Cleanroom Specialist to support sterile manufacturing by reviewing batch records for cGMP compliance, updating SOPs, and assisting with process improvements and production scheduling.

The role also manages cleanroom logbooks, supports document retention, and helps maintain inventory accuracy. Candidates should have at least two years of cleanroom manufacturing experience and strong attention to detail.

Qualifications

• At least 2 years of manufacturing experience within the cleanroom.
• Ability to communicate effectively.
• Attention to detail with a low number of errors on record.
• Knowledge of CGMP regulations and practices.
• Ability to take initiative and work independently; strong prioritization and multitasking.

Responsibilities

• Performs a review of batch records for cGMP compliance.
• Assist with process improvements including change control management.
• Updates Standard Operating Procedures.
• Assist with production schedule creation.
• Manage logbooks for the cleanroom and assist with document retention.
• Assist with inventory of the cleanroom.
• Other duties as assigned

Skills

Cleanroom experience

Effective communication

Attention to detail

Time management

Team collaboration

Education

High school diploma or equivalent

Job description

Who We Are

Fagron is the global market leader in pharmaceutical medicine, and its products are sold to more than 200,000 customers in over 60 countries.

The goal of Fagron is: Together we create the future of the personalized medicine. Fagron, together with prescribers, pharmacists, and customers, strives to improve medications and help the patient.

About the Job

The Cleanroom Specialist supports cleanroom manufacturing by reviewing batch records for cGMP compliance, updating SOPs, and assisting with process improvements and production scheduling. The role also manages cleanroom logbooks, supports document retention, and helps maintain inventory accuracy.

Key Responsibilities

• Performs a review of batch records for cGMP compliance
• Assist with process improvements including change control management
• Performs updates to Standard Operating Procedures
• Assist with the production schedule creation
• Manage logbooks for the cleanroom and assist with document retention
• Assist with inventory of the cleanroom
• Other duties as assigned

Basic Qualifications

• At least (2) years of manufacturing experience within the cleanroom.
• Ability to effectively communicate with others.
• Attention to detail with a low number of errors on record.
• High school diploma or equivalent
• Knowledge of clean room procedures
• Knowledge of and compliance with CGMP (Current Good Manufacturing Practices) regulations, practices.
• 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.
• Basic computer and math skills.
• Positive attitude and the ability to work in a team environment.

What's on Offer?

We offer a dynamic environment where talent and ambition can develop to its fullest. We have an open and informal organization culture, where individuals need to have strong motivation and ability to work independently. Fagron is a widely expanding, international, professional and ambitious pharmaceutical company with multiple growth opportunities.

Job opportunity includes competitive salary, comprehensive benefits, performance package, and ability to be part of an international leader in an expanding industry.

Ready for the challenge?

Fagron US 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. Fagron US is proud to be an affirmative action and equal opportunity employer.