Cleaning Operations Technician - 2nd Shift

Andelyn Biosciences, Inc; Columbus (OH); On-site; USD 21,000 - 28,000; Full time

Job summary

Andelyn Biosciences in Columbus, OH is seeking an entry-level Cleanroom Operator to support routine cleaning, labeling, and documentation in a controlled manufacturing environment.

Under supervision, you will perform disinfecting, gowning, and inventory tasks, ensuring GDP/ALCOA compliance and safe operations while collaborating with manufacturing, facilities, and QA teams.

Qualifications

• Must possess High School Diploma/Equivalent.
• Background in a highly regulated field, life sciences, biotechnology, and/or gene therapy industries preferred.
• Excellent communication, organization, and task management skills.
• Must be computer literate in Microsoft Office (Outlook, Excel, Word).
• Ability to work

Responsibilities

• Performs routine cleaning, disinfection, and sanitization of classified and controlled, non-classified cleanroom areas/suites, staging areas, and material airlocks in strict accordance with effective standard operating procedures. Restocks and stages locker room and cleanroom consumables, sanitizing agents, and gowning materials to maintain uninterrupted daily operational workflows.
• Prepares, labels, and handles cleanroom cleaning solutions, disinfectants/sporicides, and sanitizing chemicals in accordance with Safety Data Sheets (SDS) and site safety procedures. Adheres to designated chemical contact times, dilution protocols, and proper hazardous waste disposal requirements.
• Executes contamination control techniques using designated cleanroom mops, wipes, and specialized equipment following established unidirectional airflow and personnel flow standards. Decontaminates, inspects, and stores cleaning tools to maintain equipment in an orderly and compliant working state. Disposes gowning and cleaning waste as directed.
• Monitors and replenishes facility gowning supplies and personal protective equipment in designated areas to support continuous manufacturing readiness. Reports inventory shortages and stock discrepancies promptly to area supervisors.
• Completes all required documentation (paper and electronic) accurately and contemporaneously in alignment with Good Documentation Practices (GDP) and ALCOA++ regulatory standards. Maintains cleanroom cleanliness and documentation standards that support ongoing audit readiness and quality assurance compliance.
• Adheres strictly to facility gowning protocols, cleanroom behavior guidelines, and personal hygiene standards required for operating within classified environments. Demonstrates a working understanding of basic cleanroom principles, including room classifications, differential pressure cascades, and environmental monitoring controls.
• Works under the direct supervision of senior technicians and leadership, executing assigned routine tasks with high attention to detail. Identifies and immediately upscale facility or equipment malfunctions, procedural discrepancies, or environmental excursions to supervision.
• Actively engages in assigned training curricula, qualification programs, and hands-on demonstrations to build foundational technical competencies in cleanroom operations.
• Collaborates effectively within a diverse team environment, communicating clearly and professionally with manufacturing, engineering/facilities, and quality assurance personnel. Demonstrates personal responsibility, workplace integrity, and consistent adherence to all company safety and compliance policies.
• Performs other duties as assigned to support facility and manufacturing operations.

Skills

Attention to detail

Communication skills

Organization

Microsoft Office

Education

High School Diploma/Equivalent

Tools

Microsoft Office

Job description

Andelyn Biosciences is a biopharmaceutical Contract Development and Manufacturing Organization (CDMO) that specializes in advancing novel gene therapies from concept to commercialization.Located in Columbus, OH, the company operates out of the Andelyn Corporate Center (ACC) for clinical and commercial cGMP manufacturing of viral vectors and plasmids and the Andelyn Development Center (ADC) for preclinical non-cGMP activities.

Our Values are founded in our origin story.

The name “Andelyn”is a hybrid of two gene therapypatientswho participated in pivotal Phase I clinical trials at Nationwide Children’s Hospital. Andrew received the first U.S. investigational gene therapy for Duchenne muscular dystrophy in 2006. Evelyn received experimental gene therapy for spinal muscular atrophy in 2015. “Andelyn” combines their names to represent all the families who have courageously participated in the research that makes today’s gene therapies possible.

Through this journey, we have been able to acceleratethedevelopment and manufacturing of innovative therapies to bring more treatments to more patients. We are Turning Hope Into Reality through our ACCTSions.

A CCOUNTABLE in our actions.

C OMPASSIONATE in our thinking.

T RUSTWORTHY in our communications.

S UPPORTIVE of one another.

Employees are expected to perform the following essential functions under the framework of ourACCTSions.

• Performs routine cleaning, disinfection, and sanitization of classified and controlled, non-classified cleanroom areas/suites, staging areas, and material airlocks in strict accordance with effective standard operating procedures. Restocks and stages locker room and cleanroom consumables, sanitizing agents, and gowning materials to maintain uninterrupted daily operational workflows.
• Prepares, labels, and handles cleanroom cleaning solutions, disinfectants/sporicides, and sanitizing chemicals in accordance with Safety Data Sheets (SDS) and site safety procedures. Adheres to designated chemical contact times, dilution protocols, and proper hazardous waste disposal requirements.
• Executes contamination control techniques using designated cleanroom mops, wipes, and specialized equipment following established unidirectional airflow and personnel flow standards. Decontaminates, inspects, and stores cleaning tools to maintain equipment in an orderly and compliant working state. Disposes gowning and cleaning waste as directed.
• Monitors and replenishes facility gowning supplies and personal protective equipment in designated areas to support continuous manufacturing readiness. Reports inventory shortages and stock discrepancies promptly to area supervisors.
• Completes all required documentation (paper and electronic) accurately and contemporaneously in alignment with Good Documentation Practices (GDP) and ALCOA++ regulatory standards. Maintains cleanroom cleanliness and documentation standards that support ongoing audit readiness and quality assurance compliance.
• Adheres strictly to facility gowning protocols, cleanroom behavior guidelines, and personal hygiene standards required for operating within classified environments. Demonstrates a working understanding of basic cleanroom principles, including room classifications, differential pressure cascades, and environmental monitoring controls.
• Works under the direct supervision of senior technicians and leadership, executing assigned routine tasks with high attention to detail. Identifies and immediately upscale facility or equipment malfunctions, procedural discrepancies, or environmental excursions to supervision.
• Actively engages in assigned training curricula, qualification programs, and hands-on demonstrations to build foundational technical competencies in cleanroom operations.
• Collaborates effectively within a diverse team environment, communicating clearly and professionally with manufacturing, engineering/facilities, and quality assurance personnel. Demonstrates personal responsibility, workplace integrity, and consistent adherence to all company safety and compliance policies.
• Performs other duties as assigned to support facility and manufacturing operations.

.

What you bring to the team.

• Must possess High School Diploma/Equivalent
• Background in a highly regulated field, life sciences, biotechnology, and/or gene therapy industries preferred
• Excellent communication, organization, and task management skills with the ability to manage multiple tasks efficiently and adjust as priorities change
• Must be computer literate in Microsoft Office (Outlook, Excel, Word) at a minimum
• Ability to work