About the Job
The Asset Manager is responsible for maintaining laboratory systems and for the coordination of Calibrations, PM’s and repairs at our RTP site to ensure the efficient delivery of patient test results. Responsibilities for this role include planned maintenance, calibrations, repairs, and operational readiness of all laboratory systems, with additional support for required capital projects as they pertain to laboratory operations. The Asset Manager is also responsible for utilizing and maintaining records and workflows in the CMMS (Maximo), creating operational SOP’s, and assisting in start-up and operation of equipment and systems with effective collaboration and support to other functional areas, such as Laboratory Operations, QA Validation, Automation, and R&D.
This is a regulated position and additional information may be available from FMI Quality Assurance regarding regulatory guidelines.
• Continue the development of a high performing and operationally excellent building and workplace service support program (Maximo).
• Ensure a safe work environment is maintained through adherence to environmental and health safety guidelines, compliance and policies.
• Ensure timely review of GMP / regulated records and that work is performed accurately and in compliance with GMP, QSR, CLIA, and other regulations.
• Maintain GMP files for building equipment and instrument data, work orders, service reports, calibration certificates and other related documentation; execute good documentation practices.
• Collaborate with Procurement and Facilities in procurement and maintenance partnerships with OEMs and other maintenance vendors to maximize service levels and efficiencies for lab systems management.
• Maintain vendor relationships and support development and execution of laboratory and EHS training for onsite or external service technicians and OEM personnel.
• Support installation, repair, and troubleshooting for a wide range of instrumentation and laboratory equipment used by all functions in a CLIA, QSR and GMP environment; support on-call duties on a rotational basis.
• Assist with initiating, developing, and maintaining the maintenance and calibration work orders and spare parts inventory systems, the work request notification system, and the asset management and risk-based preventative maintenance system, ensuring work is performed in accordance with established procedures.
• Provide support to the Laboratory and Finance groups in the management and creation of data reports and metrics; assist in development of, and adherence to, a comprehensive equipment life cycle asset management.
• Create and revise applicable SOP’s and Work Plans as needed.
• Become proficient in working with the EMS (Environmental Monitoring System) and the Alarm response program.
• Maintain availability to work outside of a regularly scheduled shift.
• Domestic travel up to 10% of the time.
• Other duties as assigned.
• A Bachelor’s degree or an equivalent level of professional education and/or experience
• 3+ years of experience working in the Pharmaceutical or Device/Molecular Technology industry
• 4+ years of experience working with facilities equipment and assets
• Competency in Maximo or similar CMMS
• Experience in GMP validated environments
• Experience with commissioning and validation activities
• Demonstrated ability to anticipate challenges before they arise and to execute creative problem-solving skills to arrive at a solution
• Process oriented yet flexible. Ability to create and drive process.
• Ability to self-organize and operate effectively without significant day-to-day oversight, while staying tightly connected to key leaders and teams across collaborations
• Excellent oral and written communication and customer service skills—both upwards and downwards as well as outside the company
• Understanding of HIPAA and importance of privacy of patient data• Commitment to FMI values: patients, innovation, collaboration, and passion
Internal applicants, please use your FMI email address.