Validation Engineer II

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

Summary

The Validation Resource for Utilities and Facilities is responsible for ensuring the qualification and validation of critical utility systems and facility infrastructure in a GMP-regulated environment. This includes HVAC systems, water systems (e.g., WFI, RO/DI), cleanrooms, compressed gases, and other support utilities. This resource have to ensure compliance with industry standards and regulatory requirements while working closely with cross-functional teams to support new installations, system upgrades, and operational readiness.

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

Summary

The Validation Resource for Utilities and Facilities is responsible for ensuring the qualification and validation of critical utility systems and facility infrastructure in a GMP-regulated environment. This includes HVAC systems, water systems (e.g., WFI, RO/DI), cleanrooms, compressed gases, and other support utilities. This resource have to ensure compliance with industry standards and regulatory requirements while working closely with cross-functional teams to support new installations, system upgrades, and operational readiness.

Roles & Responsibilities

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

Education & Experience

• 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 systems such as HVAC, purified water, clean steam, gases, and cleanrooms.
• Kneat experience
• Familiarity with environmental monitoring and building management systems (Client).
• Manufacturing plant and utility environments, including cleanrooms.
• Flexibility to work extended hours or weekends during critical project phases.