GMP Environmental Monitoring Technician I

Lonza Biologics, Inc.; Houston (TX); On-site; Confidential; Full time

Benefits offered by this job

Performance-related bonus

Medical, dental and vision insurance

401(k) matching plan

Life insurance and disability coverage

Employee assistance programs

Paid time off

Night shift premium eligibility

Job summary

Lonza Biologics, Inc. is seeking an Environmental Monitoring Core Technician I to support GMP manufacturing and aseptic operations. The role involves environmental monitoring of cleanrooms, data review, and cross-functional collaboration to ensure product quality and regulatory compliance.

You will operate Solair systems, ApexZ50, and particle counters, contribute to investigations, and help maintain readiness for manufacturing activities within a cell therapy environment.

Qualifications

• 0–4 years in a cGMP manufacturing, biotechnology, pharmaceutical, or cell therapy environment.
• High School Diploma required.
• Associate Degree in Life Sciences, Engineering, or related field preferred.
• Environmental Monitoring experience preferred.
• Experience in biopharmaceutical or cell therapy manufacturing environments is highly desirable.
• 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.

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.

Skills

Verbal communication

Written communication

Time management

Organizational skills

Education

High School Diploma

Associate Degree in Life Sciences, Engineering, or related field

Tools

Microsoft Office

Quality systems software

Job description

Lonza Biologics, Inc. is seeking an Environmental Monitoring Core Technician I to support GMP manufacturing and aseptic operations. The role involves environmental monitoring of cleanrooms, data review, and cross-functional collaboration to ensure product quality and regulatory compliance.

You will operate Solair systems, ApexZ50, and particle counters, contribute to investigations, and help maintain readiness for manufacturing activities within a cell therapy environment.