Cleaning Operator Team Lead (GMP)

Biosimilar Sciences PR LLC

3d•Onsite

About The Position

Company: OcyonBio is a partnership development and manufacturing organization focused on advancing gene and cell therapies. OcyonBio provides dedicated autonomous manufacturing capacity with interconnected infrastructure and systems to support phased appropriate development for early development, pre-clinical, clinical, and commercial start. We behave more like a cGMP incubator space with all regulatory, systems capabilities, and resources to enable CMC data to support regulatory applications. Manufacturing and development spaces are designed to be autonomous while being interconnected to systems required to support clinical and commercial requirements. We strive to create a space free of both explicit and implicit discrimination and harassment where everyone feels safe, heard, and valued. The character of our employees is as important as their talent, and we’re proud of the team and environment we’re assembling as we grow. Place of Performance: CII George Sanders, Aguadilla Pueblo, Aguadilla P.R. 00603. Job Overview: The Cleaning Lead will play a critical role in the start-up and ongoing support of OcyonBio’s GMP cleanroom operations. This individual will be responsible for establishing, executing, and maintaining compliant cleaning and sanitation programs for new cleanroom facilities supporting parenteral manufacturing operations. The role requires a strong hands-on presence, deep understanding of cleanroom behaviors, and the ability to build and lead a high-performing cleaning team in a startup environment. We are looking for a motivated, detail-oriented professional with strong cleanroom experience who is comfortable working hands-on while helping to build systems and teams in a fast-paced startup environment.

Requirements

High school diploma or equivalent required; additional technical or life sciences education preferred.
Minimum of 3 years of hands-on experience working in GMP cleanroom environments.
Direct experience supporting cleaning and sanitation activities in classified areas.
Strong understanding of cleanroom behaviors, gowning, and contamination control principles.

Nice To Haves

Experience in parenteral or aseptic manufacturing operations.
Prior experience supporting cleanroom start-up or facility commissioning activities.
Experience training and leading cleaning or facilities support personnel.
Working knowledge of FDA cGMP regulations, aseptic processing guidelines, and industry best practices.
Familiarity with cleaning validation concepts and environmental monitoring interfaces.
Strong documentation skills and attention to detail.
Ability to work independently, prioritize tasks, and adapt in a startup environment.

Responsibilities

Lead the start-up and implementation of GMP-compliant cleaning and sanitation programs for newly constructed cleanrooms.
Establish routine and non-routine cleaning schedules, procedures, and workflows for classified manufacturing areas (e.g., ISO 5–8).
Perform hands-on cleaning activities within cleanroom environments in accordance with cGMPs, SOPs, and aseptic practices.
Support cleaning validation activities, including execution of protocols, sampling activities, and documentation.
Author, review, and execute SOPs, logbooks, and cleaning records in compliance with Quality Systems.
Recruit, train, and develop the cleanroom cleaning team, setting expectations for performance, compliance, and cleanroom behavior.
Train personnel on gowning practices, aseptic techniques, contamination control, and proper use of cleaning agents and equipment.
Ensure proper handling, preparation, and storage of approved cleaning and disinfecting agents.
Collaborate cross-functionally with Quality, Facilities, Engineering, and Manufacturing to support operational readiness and inspection preparedness.
Support deviation investigations, CAPAs, and continuous improvement initiatives related to cleaning and contamination control.
Demonstrate flexibility and a “roll-up-the-sleeves” mindset to meet evolving operational needs typical of a startup organization.