GMP Manufacturing Cleaning Technician

Job Description

Job Description

Job Description: GMP Manufacturing Cleaning Technician

Company: IMMUNON
Location: Huntsville, Alabama
Department: Biotech Laboratory Facilities
Reports To: Manufacturing Support Manager
Rate: $18.00 - $20.00 / hour
Status: Part-Time (@20 hours per week)
Schedule: Hourly, non-exempt (Shift TBD)

Position Summary
The GMP Manufacturing Cleaning Technician is responsible for the routine cleaning,
disinfection, and housekeeping of GMP manufacturing areas, cleanrooms, controlled
support spaces, gowning areas, airlocks, and designated laboratory/facility areas. This
role is an important part of IMMUNON’s contamination-control program and helps
maintain facilities in a state of control suitable for safe, compliant manufacturing
operations.The technician is required to strictly adhere to approved Standard Operating
Procedures (SOPs), current Good Manufacturing Practices (cGMP), Good
Documentation Practices (GDP), site safety requirements, and area-specific cleaning
methods. The technician must perform tasks in the required sequence, use only
approved materials, document work at the time it is performed, and promptly escalate
any condition that could affect product quality, personnel safety, or the controlled
environment.
Essential Duties and Responsibilities
 Perform scheduled, campaign-related, and as-needed cleaning and disinfection
of manufacturing rooms, cleanrooms, gowning areas, airlocks, corridors, and
designated support spaces in accordance with approved SOPs and cleaning
schedules.
 Clean and disinfect floors, walls, doors, windows, ceilings, work surfaces, carts,
fixtures, and equipment exteriors using approved methods and tools. Perform
product-contact equipment cleaning only when specifically trained, qualified, and
authorized.
 Prepare, label, handle, use, and store approved cleaning agents and
disinfectants in accordance with site procedures, including required


dilution/concentration, lot or preparation information, expiration/use-by periods,
contact/wet times, and applicable disinfectant rotation or sporicidal programs.
 Use designated cleanroom supplies, mops, wipes, and cleaning equipment while
maintaining separation between areas to prevent cross-contamination.

 Follow established cleaning patterns and sequences (for example, clean-to-less-
clean and top-to-bottom, when required by procedure), material-transfer
practices, room status controls, and personnel-flow restrictions.
 Complete required gowning training and qualification before entering designated
controlled areas; maintain proper gowning, hygiene, and cleanroom behavior.
 Complete cleaning logs, room/equipment records, checklists, and electronic
entries accurately, legibly, contemporaneously, and completely in accordance
with GDP requirements. Make corrections only by approved methods.
 Verify before use that cleaning materials and supplies are approved, properly
labeled, in good condition, and within applicable expiration or use periods. Do not
use unidentified, expired, or damaged materials.
 Collect, segregate, and remove routine and regulated waste using designated
containers, routes, and disposal procedures when trained and authorized.
 Report missed or incomplete cleaning, documentation errors, procedural
deviations, incorrect chemical preparation, equipment problems, and safety
concerns promptly. Stop work and seek direction when conditions are outside the
approved procedure or the technician’s training/authorization.
 Coordinate cleaning activities with Manufacturing, Quality Assurance, Facilities,
Environmental Health and Safety (EHS), and other site personnel to avoid
disruption of operations and maintain area status.
 Support inspection readiness by maintaining orderly work areas and complete
cleaning records.
 Maintain required training and qualification status, participate in refresher training
and periodic requalification, and apply training consistently on the floor.
 Monitor inventory of assigned cleaning consumables and notify supervision
before minimum stock levels are reached.
 Perform other related duties consistent with the employee’s training, qualification,
and authorization.
Performance Expectations
 Complete assigned cleaning and disinfection activities correctly and within
established schedules.
 Achieve and maintain required training and gowning qualifications.
 Follow approved procedures and contamination-control practices without
unauthorized shortcuts or substitutions.
 Maintain accurate, complete, legible, and timely documentation with minimal
documentation errors.
 Promptly communicate safety, quality, facility, and procedural concerns.
 Demonstrate dependable attendance, ownership of assigned areas, teamwork,
and care for product quality and patient safety.
 Respond constructively to coaching, observations, audits, and continuous-
improvement activities.
Quality and Compliance Expectations

 Treat cleaning and disinfection as a GMP manufacturing control: follow the
approved procedure exactly and never substitute chemicals, tools, methods, or
frequencies without authorization.
 Maintain complete data integrity and traceability in cleaning records; never pre-
document work or sign for work not personally performed or verified as required
by procedure.
 Protect the state of control of classified/controlled areas by following gowning,
material transfer, room entry/exit, and equipment segregation requirements.
 Escalate deviations and abnormal conditions promptly; do not independently “fix”
a GMP issue outside established procedures.
 Demonstrate a quality-first mindset, reliable attendance, professional conduct,
and respectful teamwork.

Required Qualifications
 High school diploma or GED equivalent required. Current college students,
particularly those pursuing studies in science, biotechnology, engineering, or a
related field, are encouraged to apply
 Ability to read, understand, and follow written procedures, chemical labels, and
safety instructions.
 Ability to complete accurate written or electronic records.
 Strong attention to detail and ability to perform repetitive tasks consistently.
 Ability to work independently and collaboratively in a controlled manufacturing
environment.
 Willingness to complete required GMP, safety, cleaning, and gowning training.

Preferred Qualifications
 1+ year of cleaning, sanitation, manufacturing support, or environmental services
experience; regulated-industry experience is strongly preferred.
 Previous experience in biotechnology, pharmaceutical, medical-device, food,
semiconductor, healthcare, or another controlled/regulated manufacturing
environment.
 Experience working in cleanrooms or controlled environments and following
gowning and material-transfer requirements.
 Familiarity with cGMP, GDP, contamination-control concepts, disinfectant contact
times, and cleanroom cleaning equipment.
 Experience with electronic logbooks, manufacturing systems, or controlled
documentation is a plus.
Physical Requirements and Work Environment

The position requires prolonged standing and walking; frequent bending, reaching, and
repetitive wiping or mopping; and pushing or pulling cleaning carts. Employees must be
able to wear required cleanroom garments and personal protective equipment for
extended periods.
Work may involve exposure to cleaning chemicals and disinfectants under established
safety controls. Lifting requirements will be based on the actual duties and equipment
used at the facility. Essential functions may be performed with or without reasonable
accommodation.

EOE