Senior Validation Engineer — GMP Compliance & Impact

Katalyst CRO; Scottsdale (AZ); On-site; USD 120,000 - 170,000; Full time

Job summary

Katalyst CRO in Scottsdale, AZ is seeking an experienced Senior Validation Specialist to lead qualification and validation activities in a GMP-regulated environment. You will plan, execute, review, and approve validation documentation for equipment, facilities, utilities, processes, and computerized systems, ensuring compliance with FDA, EMA, and cGMP requirements.

This role collaborates with Engineering, QA, Manufacturing, and Regulatory groups and mentors junior staff to drive quality and

Qualifications

• Bachelor's degree in a related field.
• 5+ years of validation experience in a GMP environment.
• Expertise in IQ/OQ/PQ and process validation.
• Experience with CSV, risk assessments, change control, and CAPA.

Responsibilities

• Lead validation lifecycle activities (DQ/IQ/OQ/PQ).
• Author, review, and approve validation protocols and reports.
• Execute validation for equipment, processes, utilities, and systems.
• Support C&Q activities for new equipment and systems.
• Manage deviations, investigations, CAPAs, and change controls.
• Develop and maintain Validation Master Plans (VMPs).
• Ensure compliance with cGMP, FDA/EMA, and data integrity.
• Support regulatory inspections and audits.
• Collaborate with Engineering, QA, Manufacturing, Automation, and Regulatory.
• Mentor junior validation engineers and specialists.

Skills

Design Qualification (DQ)

Installation Qualification (IQ)

Operational Qualification (OQ)

Performance Qualification (PQ)

Validation lifecycle management

Regulatory compliance

Education

Bachelor's degree in Engineering or related field

Tools

Kneat

ValGenesis

TrackWise

MasterControl

Job description

Katalyst CRO in Scottsdale, AZ is seeking an experienced Senior Validation Specialist to lead qualification and validation activities in a GMP-regulated environment. You will plan, execute, review, and approve validation documentation for equipment, facilities, utilities, processes, and computerized systems, ensuring compliance with FDA, EMA, and cGMP requirements.

This role collaborates with Engineering, QA, Manufacturing, and Regulatory groups and mentors junior staff to drive quality and