- Collaborate with divisional/enterprise Information teams, global infrastructure, and risk/security organizations to ensure compliant laboratory support of regulated bioanalytical laboratory programs
- Support 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 department
- Make recommendations for operational and/or technical improvements
- Communicate effectively within the group
- Coach and develop direct reports
- Plan and monitor workflows
- Monitor and approve employees’ time worked through time-entry system
- Support and promote company policies and procedures
The site is not accessible by public transportation routes/options.