Environmental Monitoring (EM) Core Technician II

Lonza•Houston, TX

2d•Onsite

About The Position

The Environmental Monitoring (EM) Core Technician II is responsible for supporting GMP manufacturing and aseptic processing activities through environmental monitoring of cleanroom operations for clinical and commercial grade products. This role helps maintain a compliant manufacturing environment by performing environmental monitoring activities, supporting cleanroom readiness, reviewing monitoring data, and collaborating with manufacturing and quality teams to ensure product quality and regulatory compliance.

Requirements

Experience from 0 to 4 years in a cGMP manufacturing, biotechnology, pharmaceutical, or cell therapy environment.
High School Diploma required.
Understanding of cGMP principles and regulated manufacturing environments.
Ability to perform aseptic manipulations and gowning procedures while maintaining cleanroom compliance.
Strong attention to detail and commitment to quality.
Self-motivated, proactive, and capable of taking ownership of assigned responsibilities.
Strong organizational, time management, verbal, and written communication skills.
Proficiency with Microsoft Office applications and quality systems software.
Ability to stand for extended periods and routinely lift up to 50 pounds.
Ability to work effectively within a collaborative team environment and adapt to changing production priorities.

Nice To Haves

Associate Degree in Life Sciences, Engineering, or a related field preferred.
Environmental Monitoring experience preferred.
Experience in biopharmaceutical or cell therapy manufacturing environments is highly desirable.

Responsibilities

Perform Environmental Monitoring activities in support of GMP production of viral vector and cell therapy products and operator qualification activities.
Coordinate environmental monitoring equipment needs with Quality Control Environmental Monitoring and other internal departments.
Draft, complete, and review environmental monitoring documentation and monitoring data records.
Prepare environmental monitoring materials and components, including operation of steam autoclaves.
Operate manual, semi-automated, and automated equipment supporting clinical and commercial cell therapy manufacturing.
Utilize environmental monitoring equipment including Solair systems, ApexZ50 units, and active particle counters.
Provide accurate data and support investigations related to environmental monitoring excursions.
Maintain inventory of environmental monitoring supplies and related materials.
Support cleanroom readiness, aseptic operations, and additional monitoring activities as required.
Partner with Manufacturing, Quality Assurance, and Quality Control teams to ensure compliance with cGMP requirements.