Lonza
Validation Engineer
US - Houston, TX
Sponsorship not specifiedDetected 26 days ago
GMPFDA RegulatoryCommunicationCollaborationWriting
About the role
- 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.
- You will work primarily in the office, with the flexibility to work remotely for 20% of your time (one day per week).
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.
- Maintain validation plans and schedules to ensure timely completion of validation activities.
- Support regulatory inspections and internal audits by providing validation documentation and expertise.
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).
- Ability to work independently and collaboratively in a fast-paced environment.
Compensation
- Compensation programs that recognize high performance.
Benefits
- https://www.lonza.com/careers/benefits.
Company info
- What we are looking for:
- 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.
- 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.
This listing is sourced directly from Lonza's careers page and normalized into a canonical job model.