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Validation Engineer
Houston, TX
The actual location of this job is in Houston, TX, US. Relocation assistance is available for eligible candidates and their families, if needed.
This is a fully site‑based role. Working together in person supports close, real‑time collaboration and the technical precision needed to manufacture medicines to the highest quality and safety standards.
This is an office‑first role. Working together in person supports close, real‑time collaboration and team alignment, enabling us to deliver our best work. You will work primarily in the office, with the flexibility to work remotely for 20% of your time (one day per week).
What you will get:
An agile career and dynamic working culture.
An inclusive and ethical workplace.
Compensation programs that recognize high performance.
A variety of benefits dependent on role and location.
The full list of our global benefits can be found here: https://www.lonza.com/careers/benefits.
What you will do:
Develop and execute validation protocols and reports for equipment, utilities, facilities. (e.g., IQ, OQ, PQ).
Develop and execute CQV deliverables for Sterilization program. Experience in autoclave cycle development, load development and qualification.
Perform risk assessments and develop validation strategies based on regulatory guidelines (e.g., FDA, EMA) and industry best practices.
Coordinate validation activities with cross-functional teams including Manufacturing, Quality Assurance, Engineering, and R&D.
Analyze validation data, identify deviations, and recommend corrective and preventive actions (CAPAs).
Prepare and present validation summaries and reports to internal and external auditors.
Participate in the review and approval of change controls related to validated systems.
Maintain validation plans and schedules to ensure timely completion of validation activities.
Support regulatory inspections and internal audits by providing validation documentation and expertise.
Contribute to the continuous improvement of validation processes and procedures.
What we are looking for:
Bachelor's degree in Engineering (Chemical, Biomedical, Mechanical, or equivalent) or a related scientific discipline.
Minimum of 3-5 years of experience in validation within the biopharmaceutical or pharmaceutical industry.
In-depth knowledge of cGMP, ICH guidelines, FDA regulations (21 CFR Parts 210, 211, 820), and other relevant regulatory requirements.
Ideal candidates will have hands-on experience in autoclave validation and familiarity with FDA and cGMP standards. Proven experience with IQ, OQ, PQ.
Strong understanding of quality systems (e.g., change control, deviations, CAPA).
Excellent technical writing and communication skills.
Ability to work independently and collaboratively in a fast-paced environment.
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 value diversity and are committed to creating an inclusive environment for all employees. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.
Ready to shape the future of life sciences? Apply now.
Learn more about this Employer on their Career Site
