Manager, QC Instrumentation Technical Lead

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BMS Cruiserath Biologics is seeking to recruit a Manager, QC Instrumentation Technical Lead. This is a Fixed-Term contract role.

Summary The QC Instrumentation Technical Lead is responsible for providing technical leadership and oversight of the QC laboratory instrumentation programme to ensure analytical equipment remains qualified, calibrated, maintained, compliant, and available to support laboratory operations. The role serves as the technical subject matter expert for instrumentation lifecycle management, instrument qualification, calibration strategies, troubleshooting, and compliance activities. The Technical Lead is responsible for leading instrumentation investigations, CAPAs and change controls, supporting regulatory inspections, evaluating instrument capability for new methods and products, and ensuring laboratory instrumentation programmes remain aligned with regulatory, compendial and corporate requirements. The position also provides technical mentoring and guidance to instrumentation specialists and laboratory personnel while supporting continuous improvement and digital transformation initiatives across the QC organisation.

Instrument Lifecycle & Qualification Lead the lifecycle management of QC analytical instrumentation, ensuring equipment remains qualified, calibrated, maintained, compliant, and available to support laboratory operations. Manage qualification activities for new and existing laboratory instruments, including installation, qualification, performance verification, periodic review, requalification, maintenance and retirement activities. Assess instrument capability, performance and suitability for analytical methods, new product introductions and evolving laboratory requirements. Compliance & Quality Systems Own instrumentation-related investigations, deviations, CAPAs and change controls, ensuring timely and eAective resolution of quality and compliance issues. Maintain inspection readiness of instrumentation programmes and associated qualification, calibration, maintenance and lifecycle documentation. Ensure instrumentation procedures, qualification activities and calibration strategies remain aligned with regulatory, compendial and corporate requirements. Technical Support & Continuous Improvement Serve as the technical SME for laboratory instrumentation, providing support for complex troubleshooting, laboratory investigations and operational challenges. Support laboratory systems and digital initiatives, including platforms such as CIMS/LIMS, Maximo, Valgeneis, LES, SmartQC and other QC electronic systems. Identify and implement opportunities to improve instrumentation reliability, compliance, eAiciency and operational performance. Inspection Readiness & Leadership Act as the instrumentation SME during regulatory inspections, audits and cross functional reviews, leading responses to instrumentation-related observations. Provide technical leadership, coaching and guidance to instrumentation specialists and laboratory personnel, fostering knowledge