CQV Engineer; Solution Preparation Systems

6+ years of CQV experience in GMP-regulated pharmaceutical or biotechnology manufacturing environments

• Commissioning, Qualification & Validation (CQV) lifecycle
• IQ/OQ/PQ protocol authoring and execution
• FAT / SAT support and equipment startup
• cGMP compliance and validation documentation
• Risk-based validation methodology

• Support commissioning, qualification, and validation activities for solution preparation systems within a GMP biopharmaceutical manufacturing environment.
• Author, review, and execute CQV lifecycle documentation including commissioning protocols, IQ/OQ/PQ protocols, and validation summary reports.
• Participate in system impact assessments, validation planning, and risk assessments aligned with regulatory expectations.
• Provide technical support for solution preparation unit operations including buffer preparation systems, media preparation systems, mixing vessels, single-use mixing systems, and solution transfer/hold systems.
• Support equipment startup and operational readiness of solution preparation processes.
• Participate in Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for new equipment installations.
• Coordinate with equipment vendors and system integrators to ensure systems are installed, tested, and performing according to design specifications.
• Work cross-functionally with engineering, automation, operations, and quality teams to resolve technical issues and ensure project milestones are met.
• Utilize electronic validation platforms such as Kneat to develop and execute validation documentation while maintaining data integrity and traceability.

• Experience with single-use bioprocessing systems
• Experience supporting biologics or cell culture manufacturing environments

• Familiarity with deviation management, change control, and CAPA processes
• Experience supporting greenfield or facility expansion projects