Validation Engineer

public.client.lonza.display.name; Houston (TX); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Agile culture

Inclusive workplace

Hands-on biomanufacturing

Competitive compensation

Job summary

Lonza is seeking a Validation Engineer for a full-time, on-site role in Houston, TX. You will execute CQV activities across equipment, utilities, and facilities, with a focus on IQ/OQ/PQ and CTU Temperature Mapping.

The role requires 2–6 years of validation engineering experience in biopharma/pharma, deep regulatory knowledge, and strong collaboration across Manufacturing, QA, Engineering, and R&D. On-site work 5 days a week on 1st shift.

Qualifications

• Bachelor’s degree in Engineering or related scientific discipline.
• 2–6 years of direct validation engineering experience in biopharmaceutical/pharma.
• Proven hands-on experience executing IQ/OQ/PQ protocols and CTU Temperature Mapping.
• Deep knowledge of cGMP, ICH guidelines, FDA 21 CFR Parts 210, 211, 820, CAPA and Change Control workflows.

Responsibilities

• Draft, execute, and review validation protocols and summary reports for equipment, utilities, and facilities (IQ/OQ/PQ).
• Develop and execute CQV deliverables for Temperature Mapping across CTUs (cold rooms, freezers, incubators).
• Coordinate validation schedules with Manufacturing, QA, Engineering, and R&D.
• Analyze validation data, investigate deviations, and recommend CAPAs.
• Review and approve change controls for validated systems and support audits.

Skills

IQ/OQ/PQ protocols

CTU Temperature Mapping

Regulatory compliance

Education

Bachelor’s degree in Engineering

Job description

Validation Engineer

Join our Validation team to play a vital role in executing critical commissioning, qualification, and validation (CQV) activities that ensure our manufacturing equipment, utilities, and facility systems perform reliably and meet global safety standards.

This is a full-time, 100% site-based role working 1st shift (Monday through Friday). Working together on-site supports direct hands‑on execution, real‑time collaboration with cross‑functional engineering teams, and the technical precision required to manufacture life‑saving medicines.

What You Will Get

• An agile career and dynamic working culture.

• An inclusive and ethical workplace.

• Direct hands‑on experience with state‑of‑the‑art biomanufacturing equipment and facilities.

• Competitive compensation.

What You Will Do

• Protocol Development & Execution: Draft, execute, and review validation protocols and summary reports for equipment, utilities, and facilities, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

• Temperature Mapping: Develop and execute CQV deliverables specifically for Temperature Mapping across Controlled Temperature Units (CTUs) such as cold rooms, freezers, and incubators.

• Cross-Functional Collaboration: Coordinate validation schedules and field activities seamlessly with Manufacturing, Quality Assurance, Engineering, and R&D teams.

• Deviation & CAPA Investigation: Analyze complex validation data, investigate test deviations, and recommend effective Corrective and Preventive Actions (CAPAs).

• Quality & Change Control: Review and approve change controls for validated systems, ensuring continuous inspection readiness and presenting validation packages during internal and external regulatory audits.

What We Are Looking For

• Education: Bachelor’s degree in Engineering (Chemical, Biomedical, Mechanical, or equivalent) or a related scientific discipline.

• Industry Experience: 2 to 6 years of direct validation engineering experience within the biopharmaceutical or pharmaceutical industry.

• Core Technical Expertise: Proven, hands‑on experience executing IQ, OQ, and PQ protocols, alongside practical expertise in CTU Temperature Mapping.

• Regulatory Compliance: In‑depth working knowledge of cGMP, ICH guidelines, FDA regulations (21 CFR Parts 210, 211, 820), CAPA processes, and Quality Change Control workflows.

• On‑Site Capability: Ability to work on‑site 5 days a week on 1st shift and effectively present validation documentation to auditors.

About Lonza

Founded in 1897 in the Swiss Alps, our business has embraced innovation and kept pace with a fast‑changing world for more than 125 years.

We are the CDMO that opened the door to a new era of medicine - one where breakthroughs could be produced at scale and made available around the world. Our contributions have led the way in drug approvals in our industry.

The therapies we help bring to life reach up to 100 million people each year, and we contribute to around one in every ten medicines that are newly approved by the FDA.

Political, regulatory, or economic disruption in one region doesn’t put the brakes on our business as our global network of 30+ sites across five continents provides resilience against global instability.

We are a community of big thinkers and bold doers. We focus on what matters, and together we make it happen. We are constantly pushing ourselves to make things better, never stopping until we make it right.

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, protected veteran status, genetic information, or any other characteristic protected by applicable federal, state, or local law.

At Lonza, we are committed to building an inclusive workplace where diverse perspectives are valued and respected. We believe that diversity strengthens our teams, drives innovation, and helps us better serve our employees, customers, and communities. Reasonable accommodations are available for qualified individuals with disabilities throughout the recruitment process.