CQV Engineer

The Commissioning Qualification Validation (CQV) Engineer is responsible for executing validation activities for equipment, facilities, and utilities in compliance with cGMP requirements. This role involves coordinating equipment installation, drafting and executing IQ/OQ/PQ protocols, and documenting validation results. The CQV Engineer will ensure validation processes align with regulatory standards and industry best practices.

Key Responsibilities:

• Lead validation activities for Facilities, Utilities, Equipment, and Processes.
• Develop and execute validation life cycle documents, including URS, DQ, FMEA, Risk Assessments, FAT, SAT, IQ, IOQ, OQ, and PQ protocols.
• Prepare and maintain validation documentation in accordance with cGMP guidelines.
• Perform IQ/OQ/PQ execution for equipment, systems, and utilities.
• Document and report validation activities, ensuring compliance with regulatory requirements.
• Identify and implement efficiency improvements in the validation program.
• Stay updated on industry regulatory changes and integrate best practices into validation activities.
• Participate in Quality Systems activities such as Document Management, Change Control, Non-Conformities, and CAPAs.
• Write and revise Standard Operating Procedures (SOPs) relevant to engineering and validation processes.
• Support Engineering in validation, requalification, and maintenance programs.
• Perform other assigned duties as required.