Senior Validation Engineer – GMP Utilities & Facilities

Katalyst CRO; Houston (TX); On-site; USD 95,000 - 135,000; Full time

Job summary

Katalyst CRO is seeking a Validation Resource for Utilities and Facilities to lead qualification and validation of critical utility systems and facility infrastructure in a GMP-regulated environment.

The role covers HVAC, water systems, cleanrooms, compressed gases, and other utilities, ensuring compliance with industry standards while collaborating with cross-functional teams on installations, upgrades, and readiness.

Qualifications

• 3-5 years of experience in commissioning, qualification, and validation of utilities and facilities in a pharmaceutical, biotech, or regulated manufacturing environment.
• Hands-on experience with HVAC, purified water, clean steam, gases, and cleanrooms.
• Kneat experience.
• Familiarity with environmental monitoring and building management systems.

Responsibilities

• Plan and execute commissioning activities for utility systems and facilities.
• Troubleshoot and resolve technical issues during commissioning.
• Author, execute, and review IQ/OQ/PQ protocols for utilities and facilities.
• Validate critical systems including HVAC balancing, environmental monitoring, water testing, and cleanroom certification.
• Ensure systems meet GMP standards and performance requirements.
• Perform thermal mapping, pressure testing, and other critical tests as needed.
• Develop and maintain documentation including protocols, validation reports, and SOPs.
• Document deviations, CAPAs, and change controls associated with facilities and utilities systems.
• Ensure traceability of qualification activities per the Validation Master Plan (VMP).
• Ensure all qualification activities meet global regulatory requirements (FDA, EMA, WHO).
• Perform risk assessments and mitigation strategies for utility and facility systems.
• Ensure compliance with 21 CFR Part 11, Annex 11, and applicable ISO standards.

Tools

Kneat

Job description

Katalyst CRO is seeking a Validation Resource for Utilities and Facilities to lead qualification and validation of critical utility systems and facility infrastructure in a GMP-regulated environment.

The role covers HVAC, water systems, cleanrooms, compressed gases, and other utilities, ensuring compliance with industry standards while collaborating with cross-functional teams on installations, upgrades, and readiness.