Validation Engineer

Lonza; Houston (TX); On-site; Confidential; Full time

Benefits offered by this job

Competitive hourly rate

Job summary

Lonza is seeking a Validation Engineer for a 6-month, site-based contract in Houston. You will develop and execute IQ/OQ/PQ protocols, perform temperature mapping for CTUs, and coordinate with Manufacturing, QA, Engineering and R&D to maintain inspection readiness.

The role requires 2–6 years in validation engineering within biopharma/pharma, strong cGMP knowledge, and the ability to work on-site five days a week. Randstad is engaged for contracting.

Qualifications

• Bachelor’s degree in engineering or related scientific field.
• 2–6 years of direct validation engineering experience in biopharma or pharmaceutical.
• Hands-on IQ/OQ/PQ protocol experience and CTU temperature mapping.
• Strong knowledge of cGMP, FDA/ICH guidelines, CAPA and change controls.

Responsibilities

• Draft, execute, and review validation protocols for equipment, utilities, and facilities (IQ, OQ, PQ).
• Develop and execute temperature mapping deliverables for CTUs (cold rooms, freezers, incubators).
• Coordinate validation schedules with Manufacturing, QA, Engineering and R&D teams.
• Investigate deviations and implement corrective and preventive actions (CAPA).
• Review and approve change controls and prep validation documentation for audits.

Skills

IQ/OQ/PQ execution

CTU Temperature Mapping

Cross-functional collaboration

cGMP knowledge

Education

Bachelor’s degree in Engineering or related

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 on 6 month contract.

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.

What you will get:

• An agile career and dynamic working culture.

• An inclusive and ethical workplace.

• Competitive hourly rate.

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

At Lonza, their people are their greatest strength. With 30+ sites across five continents, their globally connected teams work together every day to manufacture the medicines of tomorrow. Their core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who they are and how they work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work they want you to be part of.

Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, they value diversity and are committed to creating an inclusive environment.

As Lonza’s talent acquisition partner, please note, Randstad is responsible for the engagement and contracting of this contingent role.