GMP Facility Services Associate

Abzena Inc.•Bristol, PA

5d•Onsite

About The Position

With extensive experience in developing biologics and bioconjugates, Abzena offers a seamless service delivered by fully integrated teams, from early discovery to commercial manufacturing. Forward-thinking and committed, Abzena finds the best solution and uses the right technologies to design, develop and manufacture products to ensure vital medicines reach patients quickly and safely. Abzena is dedicated to quality excellence and driven to get better treatments to market, efficiently and responsibly by reducing timelines and delivering the highest quality products and services. Abzena is more than a CDMO, it is a responsible and dedicated partner that takes care of products from concept to patient. 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.

Requirements

High School diploma or GED required.
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.

Nice To Haves

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.

Responsibilities

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.