CQV Engineer

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.

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.
• Cookordination 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.