Validation Engineer

United States, Houston (Texas)

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.

Lonza Houston’s Cell and Gene Therapy Facility is the largest in the world and our facility is growing.  We are looking for professionals to grow with us and we have an exciting opportunity in our Validation group. The Validation Engineer will be responsible for the writing of and the execution of project and system qualifications, validation, re-qualifications, and revalidation of manufacturing facilities, equipment, utilities, computer systems, and processes.

Key responsibilities:

  • Generates and executes (as applicable) 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.
  • Works with Gap Assessments and Remediation Plans with an understanding of applying risk management principles. Able to work independently (author protocol, execute studies, analyze data, author reports).  
  • Advanced knowledge of discipline; 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.
  • Demonstrated ability to plan and organize validation activities among cross functional groups; capable of providing and maintaining status updates for validation activities related to day-to-day operations or project work.
  • Capable of independently discussing 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.
  • Able to correctly assess large and complex change controls with an accurate understanding of the bigger picture implications of changes.

Key requirements:

  • Bachelors’ Degree or equivalent in technical area preferred
  • Extensive experience in pharmaceutical, biotechnology a must
  • 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, among others
  • Uses experience and knowledge to solve problems, make decisions, and develop plans for the group.  Makes recommendations for the department.
  • Able to identify and respond to complex problems, interpret complex data and draw valid conclusions.
  • Demonstrated experience in management of complex tasks and projects.
  • Proficient at establishing clear and understandable directions and goals.  Provides and implements suggested resolution to roadblocks.  Able to prioritize own work and aid in setting group priorities.
  • Strong organizational skills.

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. 

    Reference: R42149