CQV Engineer: CSV & Validation Expert

Katalyst CRO; Austin (TX); On-site; USD 80,000 - 100,000; Full time

Job summary

Katalyst CRO in Austin, Texas, is seeking a motivated Validation / CQV Engineer to support qualification and validation activities in the pharmaceutical and biotech sectors. This role requires hands-on experience with IQ/OQ execution and Computer System Validation (CSV), ensuring strict adherence to compliance and regulatory standards such as 21 CFR Part 11 and GAMP guidelines. The ideal candidate will coordinate with various teams and maintain accurate validation records to support operational readiness and regulatory inspections.

Qualifications

• Hands-on experience with IQ/OQ execution and validation documentation.
• Experience in the pharmaceutical, biotech, or regulated life sciences industry preferred.
• Ability to work effectively in cross-functional regulated environments.

Responsibilities

• Execute and document IQ/OQ protocols and activities.
• Support Commissioning, Qualification, and Validation activities for systems.
• Perform Computer System Validation activities in accordance with GAMP methodologies.
• Ensure compliance with regulatory standards.
• Coordinate with teams during validation activities.
• Maintain accurate validation records.

Skills

IQ/OQ execution

Computer System Validation (CSV)

Knowledge of 21 CFR Part 11

ALCOA principles

GAMP guidelines

Strong communication skills

Analytical skills

Education

Bachelor’s degree in Engineering, Life Sciences, Biotechnology, Pharmacy, or related field

Job description

Katalyst CRO in Austin, Texas, is seeking a motivated Validation / CQV Engineer to support qualification and validation activities in the pharmaceutical and biotech sectors. This role requires hands-on experience with IQ/OQ execution and Computer System Validation (CSV), ensuring strict adherence to compliance and regulatory standards such as 21 CFR Part 11 and GAMP guidelines. The ideal candidate will coordinate with various teams and maintain accurate validation records to support operational readiness and regulatory inspections.