CQV Engineer

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

Job Summary

We are seeking a motivated and detail‑oriented Validation / CQV Engineer to support qualification and validation activities in a regulated pharmaceutical/biotech environment. The ideal candidate will have hands‑on experience in IQ/OQ execution, Computer System Validation (CSV), and validation documentation while ensuring compliance with regulatory standards including 21 CFR Part 11, ALCOA principles, and GAMP guidelines. The role involves working with laboratory systems and environmental monitoring (EM) systems to support compliance, quality, and operational readiness.

Responsibilities

• Execute and document IQ/OQ (Installation Qualification / Operational Qualification) protocols and activities.
• Support Commissioning, Qualification, and Validation (CQV) activities for laboratory and manufacturing systems.
• Perform Computer System Validation (CSV) activities in accordance with GAMP methodologies and regulatory requirements.
• Ensure compliance with 21 CFR Part 11 and ALCOA data integrity principles.
• Support validation lifecycle documentation including protocols, test scripts, reports, deviations, and change controls.
• Work with Lab Systems and Environmental Monitoring (EM) Systems to ensure validated state and compliance.
• Coordinate with Quality Assurance, Engineering, Manufacturing, and IT teams during validation activities.
• Assist in investigations, deviations, CAPA, and remediation activities related to validation systems.
• Maintain accurate validation records and ensure documentation follows GMP/GxP requirements.
• Participate in audits and inspection readiness activities as required.

Education & Experience

• Bachelor’s degree in Engineering, Life Sciences, Biotechnology, Pharmacy, or related technical field.
• Experience in pharmaceutical, biotech, or regulated life sciences industry preferred.
• Hands‑on experience with IQ/OQ execution and validation documentation.
• Knowledge of 21 CFR Part 11, ALCOA, and GAMP guidelines.
• Experience with Computer System Validation (CSV) preferred.
• Familiarity with Lab Systems and Environmental Monitoring (EM) Systems.
• Strong communication, analytical, and documentation skills.
• Ability to work effectively in cross‑functional regulated environments.