GMP Facility Services Associate in Bristol, Pennsylvania at Abzena Inc.

The GMP Facility Services Associate performs cleaning, disinfection, sanitation, and room-readiness activities within Abzena's classified and controlled GMP manufacturing areas. The role executes approved procedures and completes associated controlled documentation to ensure production spaces remain safe, compliant, organized, and ready to support scheduled manufacturing operations.

The associate works closely with Manufacturing, Quality Assurance, Materials Management, Warehouse Operations, Engineering, Facilities, and other site functions. This team member is also required to provide trained and authorized assistance within manufacturing and warehouse spaces as operational needs arise, while following all applicable gowning, safety, documentation, material-status, segregation, and contamination-control requirements

· Perform routine, campaign, turnover, and periodic cleaning and disinfection of classified and controlled GMP areas in accordance with approved SOPs, schedules, and area-specific requirements.

· Prepare, label, handle, rotate, and use cleaning agents and disinfectants in accordance with approved procedures, safety data sheets, expiration requirements, and established contact times.

· Complete cleaning records, logbooks, checklists, labels, and other controlled documentation accurately, legibly, contemporaneously, and in accordance with data-integrity expectations.

· Inspect assigned areas before and after cleaning and promptly report damage, residue, leaks, pest activity, supply shortages, documentation errors, or other conditions that could affect safety, compliance, or room readiness.

· Use dedicated tools and equipment correctly and maintain required segregation between classified areas, process areas, and non-classified spaces.

· Clean, inspect, store, and maintain mops, buckets, vacuums, carts, floor-care equipment, and other assigned tools in accordance with approved procedures.

· Maintain cleaning supplies, PPE, consumables, and disinfectant inventory at designated points of use and notify the supervisor of shortages or expiring materials.

· Follow cleanroom behavior, gowning, material-transfer, line-clearance, waste-removal, and access-control requirements for each assigned area.

· Immediately notify the supervisor and Quality Assurance of missed cleaning, spills, excursions, damaged equipment, documentation errors, or other potential quality events.

· Participate in investigations, retraining, corrective actions, change controls, risk assessments, and continuous-improvement activities related to GMP facility services.

· Support internal audits, client audits, regulatory inspections, shutdowns, and special cleaning activities as assigned.

· Participate in shift handoffs, tier meetings, daily scheduling discussions, and communication of room-readiness status and constraints.

· Provide trained and authorized support within manufacturing and warehouse spaces as needed, including room setup and turnover, material staging or movement, supply replenishment, waste removal, housekeeping, 5S activities, and other non-process operational tasks.

· Verify material labels and status before movement and follow all chain-of-custody, segregation, temperature, and storage requirements applicable to assigned warehouse support tasks.

· Stop work and escalate any condition that may compromise employee safety, product quality, material status, data integrity, or contamination control.

· Perform other duties consistent with the role and business needs as assigned by Abzena management.

Physical Requirements

· Ability to work in office, GMP manufacturing, cleanroom, warehouse, utility, and general facility environments.

· Ability to wear required personal protective equipment (PPE) and cleanroom gowning for extended periods.

· Ability to stand and walk for extended periods and perform frequent bending, reaching, pushing, pulling, and repetitive cleaning motions.

· Ability to safely use ladders, carts, mops, vacuums, floor-care equipment, and other approved cleaning tools as required by the role.

· Ability to lift and move up to 50 pounds occasionally, with or without reasonable accommodation.

· Ability to work assigned shifts and occasional weekends, holidays, off-shift hours, or extended hours based on manufacturing and site needs.

· High School diploma or GED required.

· At least 1 year of experience in GMP cleaning, pharmaceutical or biotechnology manufacturing, cleanroom operations, sanitation, warehouse operations, or a related regulated environment preferred.

· Working knowledge of cGMP, cleanroom behavior, gowning, controlled documentation, data integrity, and cleaning and disinfection practices preferred.

· Ability to read, understand, and consistently follow SOPs, cleaning schedules, labels, safety data sheets, and written work instructions.

· Ability to perform accurate basic calculations and measurements associated with cleaning-agent preparation and inventory activities after training.

· Strong attention to detail, dependability, organization, and willingness to identify and report errors or abnormal conditions.

· Ability to communicate clearly and work effectively with Manufacturing, Quality, Warehouse, Facilities, and other cross-functional teams.

· Basic computer skills and the ability to learn Abzena electronic training, quality, maintenance, and enterprise systems.

FLSA: Non-Exempt

Abzena is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, and training.