Senior CQV Engineer – Validation & Compliance

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

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.