Biotechnology Quality Engineer
United States, Houston (Texas)
Today Lonza is a global leader in life sciences. We are more than 15,000 employees in more than 100 locations around the world. 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 Head of Validation 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. Track and report action plan status/ completion as it relates to validation systems improvement efforts. Responsible for the quality and engineering aspects of development and the execution of qualifications, validations, re-qualifications and re-validation for process equipment, laboratory equipment, utilities and facilities.
- Demonstrated ability to plan and oversee validation activities amongst cross functional groups; capable of providing and maintaining status updates for validation activities related to day-to-day operations or project work.
- Provides Quality oversight to ensure compliance with applicable regulations and industry standards
- Support continuous improvement to Quality engineering systems, including: process, equipment, facilities, utilities, and computer systems.
- Serve as an integral resource related to Quality, Engineering, Facilities and Validation organizations
- Execution of efficiency and ensuring on-time delivery of all areas related to QA.
- Reviews from the quality and engineering perspective Validation Project Plans, Validation Protocols – Installation Qualifications/Operational Qualifications/Performance Qualifications (IQ/OQ/PQ) and summary reports and SOPs as required by LONZA site’s Validation Master Plan, SOPs and global policies. Systems include incubators, Biosafety Cabinets (BSCs), Autoclaves, Bioreactors, Process Gases, Deionized (DI) water system, Classified Clean Rooms/Heating, Ventilation, Air Conditioning (HVAC) (Grades, A through D), among others
- Works with Gap Assessments and Remediation Plans with an understanding of applying risk management principles.
- Able to work independently (audit protocols, studies, analyze data, author reports).
- Bachelors Degree in Science, Engineering or related field
- Advanced knowledge of Quality Engineering Systems disciplines: Commissioning, Qualifications, Calibrations/Maintenance, HEPA Certifications, Drawings Management, discipline.
- 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
- cGMP Manufacturing Support expeerince required
- Fundamental understanding of validated computer systems and change management in the commercial pharmaceutical/biotech industry, including training others.
- GMP compliance knowledge
- Ability to write complex procedures and reports
- Able to discuss regulatory expectations for validation activities, program and documentation.
- Able to handle some larger and more complicated project work but with oversight at a moderate degree.
- 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-III level personnel and or Engineering personnel.
- Able to correctly assess large and complex change controls with an accurate understanding of the bigger picture implications of changes. May still need some review and oversight or feedback
- Knowledge of SAP and TrackWise systems a plus.
Every day, Lonza’s products and services have a positive impact on millions of people. 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.