Quality Engineering & Validation Consultant

We are seeking an experienced Quality Engineering & Validation Consultant to provide GMP Quality oversight in support of manufacturing operations, validation activities, and capital projects within a regulated biopharmaceutical environment. This individual will partner cross-functionally with Manufacturing, Engineering, Validation, Facilities, Materials Management, and Quality teams to ensure compliance with GMP requirements while supporting clinical and commercial operations. This role is ideal for a hands‑on Quality professional with strong validation, investigation, and CAPA experience who thrives in a fast‑paced manufacturing environment. Responsibilities Provide Quality oversight for GMP manufacturing operations, validation activities, and capital projects supporting clinical and commercial production. Review and approve quality documentation, including change controls, validation protocols, risk assessments, investigations, and CAPAs. Partner cross‑functionally with Manufacturing, Engineering, Validation, Facilities, Laboratory Operations, and Materials Management to ensure GMP compliance. Support equipment, facility, and utility qualification activities, including calibration, preventive maintenance, work orders, and instrument qualification. Review and approve equipment, facility, and utility trending programs while identifying compliance risks and driving resolution of quality issues. Support environmental monitoring, facility control systems, and related quality programs to ensure inspection readiness and regulatory compliance. Apply risk‑based decision making while identifying process improvements and communicating quality risks to project teams and leadership. Qualifications BS degree in Engineering, Life Sciences, or a related technical discipline (Master's degree preferred). 8+ years of Quality Assurance experience supporting GMP manufacturing operations within the pharmaceutical, biotechnology, or cell & gene therapy industry. Experience providing Quality oversight for validation activities, engineering projects, and capital equipment. Strong experience leading or supporting GMP investigations, root cause analysis, CAPA, change controls, and risk assessments. Working knowledge of aseptic manufacturing and GMP regulations. Experience with electronic quality systems such as Veeva, Nuvolo, ViewLinc, or similar platforms. Excellent communication, collaboration, and problem‑solving skills with the ability to work effectively across cross‑functional teams. Preferred Qualifications Experience supporting cell and gene therapy manufacturing. Experience working in both clinical and commercial manufacturing environments. Strong understanding of equipment qualification, facility validation, and utilities within GMP operations. #J-18808-Ljbffr Redbock - an NES Fircroft company