Validation Engineer

Lonza • Houston, TX

3d • Hybrid

About The Position

The Validation Engineer role is a fully site-based position located in Houston, TX, US. This role is office-first, emphasizing close, real-time collaboration and technical precision for manufacturing medicines to the highest quality and safety standards. While primarily office-based, there is flexibility for remote work one day per week (20% of the time). The position offers an agile career and dynamic working culture within an inclusive and ethical workplace, with compensation programs that recognize high performance and a variety of benefits dependent on role and location.

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.
• 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.

Nice To Haves

• Ideal candidates will have hands-on experience in autoclave validation and familiarity with FDA and cGMP standards.

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.
• 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.

Benefits

• Relocation assistance is available for eligible candidates and their families, if needed.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level