Collaborate with divisional/enterprise Information teams, global infrastructure, and risk/security organizations to ensure compliant laboratory support of regulated bioanalytical laboratory programsSupport the lifecycle of GxP equipment including the acquisition, installation, maintenance, and retirement phases.Apply deep expertise in the computer system validation process for diverse laboratory equipment such as automated liquid handlers, plate readers, and PCR systems.Maintain service schedules for instrument maintenance, ensuring timely completion of calibration and maintenance activities in accordance with departmental SOPs.Coordinate service activities involving various vendors, service engineers, and facilities staff, fostering strong professional relationships.Develop a working knowledge of laboratory equipment, like liquid handlers, plate washers/readers, and PCR.Serve as system administrator for equipment applications, including temperature monitoring systems, assisting in the management of controlled temperature units and alarm handling.Collaborate with lab ops staff across bioanalytical labs and sites for process improvement, cross-training and cross-site support.Engage in the routine operations supports promoting a culture of continuous improvement.Assist in the development of reporting, analytics and visualization solutions to support local clinical operations and administrative business processes.Ensuring automation systems are maintained in a validated state, as part of an active/ongoing lifecycle management program and in compliance with current GXP requirements.Reviewing documents, preventive maintenance, and Standard Operating Procedures to ensure compliance with GxP Practice and corporate safety requirements.Enhance the existing LAMP infrastructure to track equipment preventative maintenance (PM) within the client’s department.Provide compliance support activities such as entering PM and corrective maintenance services in the electronic laboratory logbook.Oversee outsourced pipette calibration, maintaining records in the electronic logbook. Generate and review out-of-calibration impacts reports, share it with management and take appropriate actions.Perform Hamilton verification after PM/CM, documenting verification in the electronic logbook.Utilize technical knowledge to ensure efficient operation of various automated processing and informational technology systems.Participate in compliance audits and training programs.Providing client services support for business area laboratory applications.Leadership Responsibilities:Act as a technical resource, trainer, and troubleshooter for the departmentMake recommendations for operational and/or technical improvementsCommunicate effectively within the groupCoach and develop direct reportsPlan and monitor workflowsMonitor and approve employees’ time worked through time-entry systemSupport and promote company policies and proceduresThe site is not accessible by public transportation routes/options.
