Sr. Validation & Compliance Engineer

Katalyst CRO; Indianapolis (IN); On-site; USD 100,000 - 140,000; Full time

Job summary

Katalyst CRO is seeking a Sr. Validation & Compliance Engineer to support commissioning, qualification, and validation (CQV) activities for equipment, utilities, and facilities within a regulated pharmaceutical/biotech manufacturing environment.

The role involves developing and executing IQ/OQ/PQ protocols, supporting process validation and technology transfer activities, ensuring compliance with FDA/EMA regulations, and collaborating cross-functionally to deliver compliant and inspection-ready

Qualifications

• Bachelor's or Master's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or related technical discipline.
• 5+ years of CQV experience in pharma/biotech FDA-regulated environments.
• Experience with IQ/OQ/PQ protocols and validation documentation.
• Strong technical writing and cross-functional collaboration skills.

Responsibilities

• Develop, execute, and document IQ/OQ/PQ for equipment, utilities, and facilities.
• Author, review, and approve qualification protocols and validation reports.
• Perform risk-based commissioning and qualification activities per FDA/EMA/cGMP standards.
• Coordinate with Engineering, QA, Validation, Manufacturing, and Operations teams across CQV lifecycle.
• Support technology transfer activities and handover of validated systems to manufacturing.
• Participate in deviation investigations, CAPA, and process improvements.
• Ensure validation activities comply with GDP and data integrity expectations.
• Assist change control assessments and maintenance of validated systems.
• Support inspection readiness and provide validation documentation for audits.

Skills

IQ/OQ/PQ protocols

Technical writing

Validation lifecycle

Cross-functional collaboration

FDA/EMA knowledge

Problem solving

Education

Engineering/Pharma degree

Job description

We are seeking a Sr. Validation & Compliance Engineer to support commissioning, qualification, and validation (CQV) activities for equipment, utilities, and facilities within a regulated pharmaceutical/biotech manufacturing environment. The role involves developing and executing IQ/OQ/PQ protocols, supporting process validation and technology transfer activities, ensuring compliance with FDA/EMA regulations, and collaborating cross-functionally to deliver compliant and inspection-ready systems. The ideal candidate will possess strong technical writing, problem-solving, and validation lifecycle management experience.

Job Summary

We are seeking a Sr. Validation & Compliance Engineer to support commissioning, qualification, and validation (CQV) activities for equipment, utilities, and facilities within a regulated pharmaceutical/biotech manufacturing environment. The role involves developing and executing IQ/OQ/PQ protocols, supporting process validation and technology transfer activities, ensuring compliance with FDA/EMA regulations, and collaborating cross-functionally to deliver compliant and inspection-ready systems. The ideal candidate will possess strong technical writing, problem-solving, and validation lifecycle management experience.

Roles & Responsibilities

• Develop, execute, and document commissioning, qualification, and validation protocols (IQ/OQ/PQ) for new and modified equipment, utilities, and facilities.
• Author, review, and approve qualification protocols, test scripts, deviation reports, and validation summary reports.
• Perform risk-based commissioning and qualification activities in alignment with FDA, EMA, cGMP, and internal quality standards.
• Coordinate with Engineering, Quality Assurance, Validation, Manufacturing, and Operations teams throughout the CQV lifecycle.
• Support technology transfer activities, process validation, and successful handover of validated systems to manufacturing.
• Participate in deviation investigations, root cause analysis, CAPA implementation, and continuous improvement initiatives.
• Ensure all validation activities are executed in compliance with GDP, data integrity, and regulatory expectations.
• Assist with change control assessments, periodic reviews, and maintenance of validated systems.
• Support inspection readiness activities and provide validation documentation during internal/external audits.

Education & Experience

• Bachelor's or Master's degree in Engineering, Life Sciences, Pharmaceutical Sciences, or a related technical discipline.
• Minimum 5+ years of experience in commissioning, qualification, and validation (CQV) within pharmaceutical, biotech, or FDA-regulated industries.
• Hands-on experience with equipment qualification, utilities validation, and facility commissioning activities.
• Strong knowledge of cGMP, FDA, EMA, and industry validation standards.
• Proven experience authoring and executing IQ/OQ/PQ protocols and validation documentation.
• Experience with deviation management, CAPA systems, and risk assessment methodologies.
• Excellent technical writing, communication, and cross-functional collaboration skills.
• Familiarity with process validation, technology transfer, and manufacturing support activities preferred.