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The F&E Technical Services Manager is a key member of the Site Facilities & Engineering and technical team. With primary responsibility for leading the QC Technical Services function, the manager will also manage the Amgen calibration equipment and standards lifecycle. The role ensures the reliable, compliant, and efficient lifecycle management of the applicable equipment at the Amgen Dun Laoghaire site. The position combines day-to-day operations and project responsibilities. The day-to-day operations include hands-on technical leadership, equipment maintenance and people management. The role also involves project work including the introduction of new capabilities in partnership with specialist project engineers and external service providers.
Job Responsibility:
Lead, coach, and develop a team of Technical Specialists
set clear objectives, manage performance, and support succession and capability development
Plan, prioritize, and coordinate team workloads to meet operational demands and project timelines
Promote a culture of technical excellence, compliance, safety, and continuous improvement
Oversee calibration, requalification, and routine maintenance of QC laboratory equipment utilizing the site CMMS system (Maximo/SAP)
Own and govern the qualification lifecycle for new and existing laboratory equipment, including protocol review and approval
Ensure periodic review and ongoing compliance of validated QC equipment and systems
Oversee calibration, requalification, and routine maintenance of Calibration equipment systems and Standards utilizing the site CMMS system (Maximo/SAP)
Represent ADL as the calibration representative within the global metrology network
Support alignment with enterprise standards and contribute to cross‑site improvement initiatives
Ensure robust data integrity controls aligned with regulatory expectations (e.g. electronic records and audit trails)
Support deviations, investigations, CAPAs, and change controls related to applicable equipment and systems
Ensure continuous inspection readiness and support regulatory and internal audits
Partner with specialist project engineers to deliver laboratory equipment upgrades and new capabilities
Provide technical input to capital and improvement projects from design through commissioning and handover
Collaborate closely with QC Operations, Manufacturing, QA, Engineering, Validation, Technology, EHS, and external vendors
Manage key service providers and vendors to minimize equipment downtime and maintain high service standards
Track KPIs, analyze trends, and drive continuous improvement initiatives to improve equipment reliability and performance
Requirements:
Bachelor’s degree in Science, Engineering, or a related discipline
Significant experience in a cGMP-regulated QC laboratory environment with expertise in laboratory equipment operation, qualification and maintenance
Prior experience leading or supervising technical professionals
Strong knowledge of regulatory expectations for QC laboratory equipment and computerized systems
Understanding of analytical techniques and instrumentation utilized in biopharmaceutical methods and testing
Experience with calibration processes and principles
Nice to have:
Master’s degree in a relevant scientific or engineering discipline
Experience acting as system owner for QC laboratory equipment or computerized systems
Demonstrated success delivering equipment-related projects in a regulated environment
Experience working with CMMS systems such as Maximo
Strong leadership, communication, and stakeholder influencing skills