Quality Engineer at US05 Lonza Houston Inc. in Houston, Texas

Job Description:

Today, Lonza is a global leader in life sciences operating across three continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that’s the kind of work we want to be part of.

The Quality Engineer will support the QA Validation team by ensuring effective Quality oversight for Engineering day-to-day functions and projects validations documentation development and execution and calibrations/maintenance documentation of manufacturing equipment, facilities and process utilities. Quality oversight of all validation activities related to Capital Projects such as but not limited to the initial qualification of all new equipment bring onsite, cleanrooms qualifications, and utilities qualifications to ensure that are in compliance with Lonza procedures. Evaluated Validation Project Plans, Installation Qualifications, Operational Qualifications, Performance Qualifications (IQ/OQ/PQ), summary reports, URS and SOPs as required by LONZA, and global policies from the quality and engineering perspective.

Key responsibilities:

• Provides Quality oversight to ensure compliance with applicable regulations and industry standards.


• Serve as an integral resource related to Quality, Engineering, Facilities, and Validation organizations.


• Reviews from the quality and engineering perspective Validation Project Plans, Validation protocols (IQ/OQ/PQ) and Summary Reports and SOPs as required LONZA site’s Validation Master Plan, SOPs and global policies. Systems include incubators, BSCs, Autoclaves, Bioreactors, process gases, DI water system, Classified Clean Rooms/HVAC (Grades, A through D), among others.


• Interacted and communicate directly with customers to discuss deviations and/or validation plans for a specific equipment or program.


• Approve the resolution of discrepancies encountered during protocol execution.

Key requirements:

• Bachelors: Life Sciences or Engineering required   


• 5-7 years’ experience within Quality Assurance and Validations


• Thorough knowledge of validation life cycle, validation protocols (IQ/OQ/PQ) generation and execution of manufacturing and laboratory equipment, clean process utilities and classified facilities.


• Fundamental understanding of validated computer systems and change management in the commercial pharmaceutical/biotech industry, including training others.


• GMP compliance knowledge including knowledge of 21 CFR Parts 210, 211, 11, GAMP 5 and ISO 13485:2003 requirements, data integrity among others.


• Calibrations Program/Maintenance Program


• Advanced knowledge of Quality Engineering Systems disciplines (Commissioning, Qualifications, Calibrations/Maintenance, HEPA Certifications, Drawings Management, discipline; able to discuss regulatory expectations for validation activities, program and documentation).


• Capable of independently discussing Quality Engineering and validation philosophies during customer audits or regulatory inspections in the presence of the Manager.


• Would be able to correctly answer questions about day-to-day activities that would be most likely posed by Validation Engineer I-IV level personnel and/or Engineering personnel. 

For us, this is not only a great privilege, but also a great responsibility. How we achieve our business results is just as important as the achievements themselves. At Lonza, we respect and protect our people and our environment. Any success we achieve is no success at all if not achieved ethically.

People come to Lonza for the challenge and creativity of solving complex problems and developing new ideas in life sciences. In return, we offer the satisfaction that comes with improving lives all around the world. The satisfaction that comes with making a meaningful difference.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.