Sr. Validation & Compliance Engineer

Katalyst CRO; Indianapolis (IN); On-site; USD 80,000 - 110,000; Full time

Job summary

Katalyst CRO is seeking a Sr. Validation & Compliance Engineer in Indianapolis to support commissioning, qualification, and validation for pharmaceutical manufacturing. This role requires developing IQ/OQ/PQ protocols, ensuring compliance with FDA regulations, and collaborating with cross-functional teams. Ideal candidates hold a Bachelor's or Master's degree in Engineering or Life Sciences with a minimum of 5 years' experience in the regulated industry. The role demands excellent technical writing and risk assessment skills.

Qualifications

• Minimum 5+ years of experience in CQV within FDA-regulated industries.
• Strong knowledge of FDA and industry validation standards.
• Experience with deviation management and risk assessment methodologies.

Responsibilities

• Develop and execute commissioning, qualification, and validation protocols (IQ/OQ/PQ).
• Coordinate with Engineering, Quality Assurance, and Manufacturing teams.
• Support inspection readiness activities and provide validation documentation.

Skills

Commissioning and qualification

cGMP knowledge

Technical writing

Cross-functional collaboration

Education

Bachelor's or Master's degree in Engineering or Life Sciences

Job description

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.

• 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.