Environmental Monitoring (EM) Core Technician II

Lonza Group; Houston (TX); Vor Ort; USD 55.000 - 75.000; Vollzeit

Benefits dieser Stelle

Performance bonus

Medical, dental and vision insurance

401(k) matching

Life insurance

Disability insurance

Employee assistance program

PTO

Night shift premium

Zusammenfassung

Lonza is seeking an Environmental Monitoring Core Technician II in Houston, TX to support GMP manufacturing and aseptic processing for viral vector and cell therapy products. You will perform environmental monitoring, help maintain cleanroom readiness, review data, and collaborate with Manufacturing and Quality teams to ensure product quality and regulatory compliance.

The role offers experience with Solair systems, ApexZ50 units, and particle counters, along with documentation and cGMP

Qualifikationen

• 0–4 years in a cGMP manufacturing, biotech, pharma, or cell therapy environment.
• High School Diploma required.
• Associate Degree in Life Sciences, Engineering, or related field preferred.
• Environmental Monitoring experience preferred.
• Biopharmaceutical or cell therapy manufacturing experience desirable.
• Understanding of cGMP principles and regulated manufacturing environments.
• Aseptic manipulations and gowning to maintain cleanroom compliance.
• Attention to detail and commitment to quality.
• Self-motivated, proactive, and ownership of responsibilities.
• Strong organizational, time management, verbal and written communication.
• Proficiency with Microsoft Office and quality systems software.
• Ability to stand extended periods and lift up to 50 pounds.
• Collaborative, adaptable to changing production priorities.

Aufgaben

• Perform Environmental Monitoring activities in GMP production of viral vector and cell therapy products.
• Coordinate environmental monitoring equipment needs with QC Environmental Monitoring and other departments.
• Draft, complete, and review environmental monitoring documentation and data records.
• Prepare environmental monitoring materials, including steam autoclave operation.
• Operate manual, semi-automated, and automated equipment for clinical and commercial manufacturing.
• Utilize environmental monitoring equipment including Solair systems, ApexZ50, and particle counters.
• Provide 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.
• Partner with Manufacturing, Quality Assurance, and Quality Control to ensure cGMP compliance.

Kenntnisse

Attention to detail

Time management

Verbal communication

Written communication

Microsoft Office

Quality systems software

Gowning procedures

cGMP knowledge

Team collaboration

Ausbildung

High School Diploma

Associate degree

Life Sciences degree

Tools

Solair systems

ApexZ50 units

Particle counters

Steam autoclaves

Jobbeschreibung

United States, Houston (Texas)

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.

What you will get:

• Performance-related bonus.
• Medical, dental and vision insurance.
• 401(k) matching plan.
• Life insurance, as well as short-term and long-term disability insurance.
• Employee assistance programs.
• Paid time off (PTO).
• Night shift premium eligibility.

Compensation for this role will be determined by the candidate’s qualifications, skills, experience, and relevant knowledge.

What you will do:

• 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.

What we are looking for:

• Experience from 0 to 4 years in a cGMP manufacturing, biotechnology, pharmaceutical, or cell therapy environment.
• High School Diploma required.
• 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.
• 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.

About Lonza:

At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Reference: R78542

You will feel at home at Lonza if you:

• Take ownership, step forward, and enjoy meaningful responsibility
• Love solving problems and thrive in a complex, fast-moving environment
• Are curious, always looking to learn and improve
• Work collaboratively, contributing to something bigger than yourself
• Are motivated to make a difference through work that impacts customers and their patients

Why Lonza:

We are a place of unique opportunity, where your ideas, expertise and ambition can make a real difference. Here, will have the freedom to grow, the support to succeed and the chance to contribute to work that matters.

We are the makers of the medicines of tomorrow.