What are the responsibilities and job description for the CQV Engineer position at Katalyst CRO?
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.
Roles & Responsibilities
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.
Roles & 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.
- 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.