Job Title
Global Device Engineering Lab Manager
Requisition
JR000015971 Global Device Engineering Lab Manager (Open)
Location
Dublin, IRL
Additional Locations
Job Description Summary
The Global Device Engineering (GDE) Laboratory Manager is a key member of the GDE team responsible for the effective, efficient and compliant running of the engineering labs and storage. The role is responsible for lab infrastructure, lab equipment management, quality and EHS compliance, to facilitate efficient medical device product development activities in both GxP and non-GxP environments.
A successful Laboratory Operations Manager demonstrates strong organizational skills, attention to detail, accountability, and a proactive approach to quality, safety, and continuous improvement. They are a collaborative leader who balances compliance and operational excellence with fostering a positive, patient-focused, agile laboratory culture.
Job Description
Laboratory Equipment Management
Manage the full lifecycle of laboratory equipment and instrumentation, including procurement, qualification (IQ/OQ/PQ), Computer System Validation (CSV), commissioning, maintenance, and retirement.
Coordinate equipment vendors and service providers to ensure timely installation, calibration, maintenance, repair, and technical support.
Develop and maintain preventive maintenance schedules and calibration programs in accordance with manufacturer recommendations, quality requirements, and regulatory standards, on Blue Mountain RAM.
Establish and maintain equipment work instructions, operating procedures, and technical documentation.· Investigate equipment-related deviations, including out-of-calibration events, and implement appropriate corrective and preventive actions.
Maintain laboratory asset records and equipment inventory within Blue Mountain RAM and SAP.· Deliver equipment-specific training and support to laboratory personnel to ensure safe and effective equipment operation.
Quality Management
Maintain compliance with cGMP, quality systems, data integrity requirements, and corporate standards across all laboratory activities.
Support and manage Quality System processes, including Change Control, Out of Specification (OOS) investigations, equipment qualification, CSV, and laboratory labeling requirements.
Own and maintain laboratory SOPs and controlled documentation, ensuring alignment with current regulatory and business requirements.
Monitor laboratory compliance metrics and generate periodic reports to support management review and continuous improvement activities.
Collaborate with Quality Assurance and cross-functional teams on audit preparation, address audit observations, deviations, CAPAs, and compliance initiatives.
Promote a quality-focused culture through adherence to procedures, documentation standards, and best practices.
Environmental Health & Safety (EHS)
Ensure compliance with site EHS policies, regulatory requirements, and corporate safety standards within the laboratory environment.
Coordinate and maintain laboratory risk assessments for equipment, testing activities, chemicals, and operational processes.
Manage the safe handling, storage, and disposal of chemicals, pharmaceutical materials, gases, and laboratory waste.
Maintain Safety Data Sheets (SDS), chemical inventories, and PPE stock levels to support safe laboratory operations.
Act as an active participant in EHS committees, audits, inspections, and incident investigations.
Collaborate with Facilities and Engineering teams to support gas management, chemical storage, and laboratory safety systems.
Drive a proactive safety culture through hazard identification, risk mitigation, training, and continuous improvement initiatives.
Laboratory Operations Management
Oversee day-to-day laboratory operations, ensuring efficient, effective, and compliant execution of laboratory activities.
Drive operational excellence through Gemba walks, Tier Board management, Kaizen, Kanban, and continuous…