Career Category

Engineering

Job Description

Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. With a deep and broad pipeline of potential new medicines, we continue to advance science to serve patients. Amgen Dun Laoghaire (ADL) activities include Biopharmaceutical Aseptic Manufacturing, Lyophilisation and Automated Inspection & Packaging.

Role Purpose

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.

Key Duties and Responsibilities:

Technical Leadership & People Management:

• 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.

QC Equipment Lifecycle Management:

• 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

Calibration Systems & Standards Lifecyle Management:

• 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.

Data Integrity, Compliance & Inspection Readiness

• 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.

Projects, Upgrades & Cross-Functional Collaboration

• 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.

Operational Excellence & Vendor Management:

• 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.

Basic Qualifications & Experience:

• 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.

Preferred Qualifications & Experience:

• 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.

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