Cleanroom Specialist (1st Shift)

Fagron Nederland BV; Wichita (KS); On-site; USD 52,000 - 72,000; Full time

Benefits offered by this job

Competitive salary

Benefits package

Career growth opportunities

Job summary

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

You will manage cleanroom logbooks, support document retention, and help maintain inventory accuracy while collaborating with a cross-functional team to meet tight deadlines.

This role requires strong attention to detail and the ability to work independently or in team settings.

Qualifications

• Two years manufacturing experience in a cleanroom.
• Strong communication skills.
• Attention to detail with low error rate on records.
• Knowledge of cleanroom procedures.
• Understanding of CGMP regulations and practices.
• Ability to work independently and take initiative.
• Time management and ability to adapt to changing priorities.
• Ability to handle multiple tasks and meet deadlines.

Responsibilities

• Review batch records for cGMP compliance.
• Assist with process improvements including change control management.
• Update Standard Operating Procedures.
• Assist with the production schedule creation.
• Manage cleanroom logbooks and support document retention.
• Assist with cleanroom inventory.
• Other duties as assigned.

Skills

Batch records

CGMP compliance

SOP updates

Process improvement

Production scheduling

Logbook management

Inventory control

Teamwork

Communication

Attention to detail

Education

High school diploma or equivalent

Job description

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.

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.

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.