Validation Engineer

Responsibilities

• 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.

Requirements

• 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
• Ready to shape the future of life sciences?

Benefits

Additional Information

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 .

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