GMP Cleanroom Facilities Specialist

Abzena; Bristol Township (Bucks County); On-site; USD 42,000 - 54,000; Full time

Job summary

Abzena in Bucks County, PA, seeks a GMP Facility Services Associate to perform cleaning, disinfection, and room-readiness in classified GMP areas. You will execute approved procedures and maintain documentation to keep production spaces safe, compliant, and ready for manufacturing operations.

You will work with Manufacturing, Quality Assurance, Materials Management, Warehouse, Engineering, and Facilities, providing trained support, following gowning and contamination-control requirements, and

Qualifications

• High School diploma or GED required.
• At least 1 year of GMP cleaning, pharmaceutical or biotech manufacturing, cleanroom operations, sanitation, or related regulated environment preferred.
• Working knowledge of cGMP, cleanroom behavior, gowning, controlled documentation, data integrity, and cleaning/disinfection practices preferred.
• Ability to read, understand, and follow SOPs, cleaning schedules, labels, safety data sheets, and work instructions.
• Ability to perform basic calculations and measurements for cleaning-agent preparation and inventory after training.
• Strong attention to detail, dependability, organization, and willingness to report errors or abnormal conditions.
• Ability to communicate clearly with Manufacturing, Quality, Warehouse, Facilities, and other cross-functional teams.
• Basic computer skills and ability to learn Abzena electronic training, quality, maintenance, and enterprise systems.

Responsibilities

• Perform routine and campaign cleaning of GMP areas per SOPs and area requirements.
• Prepare, label, handle, rotate, and use cleaning agents with proper safety and contact times.
• Complete cleaning records, logbooks, checklists, labels, and documentation accurately.
• Inspect areas before/after cleaning and promptly report damage, residue, leaks, or shortages.
• Use dedicated tools and maintain segregation between classified and non-classified spaces.
• Clean, inspect, store, and maintain cleaning tools and equipment.
• Maintain supplies, PPE, and disinfectant inventory; notify shortages or expiring materials.
• Follow cleanroom behavior, gowning, material-transfer, and contamination-control requirements.
• Notify supervisor/QA of missed cleaning, spills, or quality events.
• Participate in investigations, retraining, corrective actions, and continuous-improvement activities.
• Support internal audits, client audits, regulatory inspections, shutdowns, and special cleanings.
• Participate in shift handoffs and daily scheduling discussions followed by room-readiness updates.
• Provide trained support in manufacturing and warehouse spaces including room setup and turnover.

Skills

Attention to detail

Teamwork

Education

High School diploma or GED

Job description

Abzena in Bucks County, PA, seeks a GMP Facility Services Associate to perform cleaning, disinfection, and room-readiness in classified GMP areas. You will execute approved procedures and maintain documentation to keep production spaces safe, compliant, and ready for manufacturing operations.

You will work with Manufacturing, Quality Assurance, Materials Management, Warehouse, Engineering, and Facilities, providing trained support, following gowning and contamination-control requirements, and