About the position
The Cell Manufacturing Core Facility (CMCF), and GMP Facility Equipment Manager reports to the CMCF Business Director. The position is responsible for the performance, organization and oversight of maintenance of the CMCF cGMP cleanroom spaces, equipment and supporting utilities. This position has several key roles and will interface with key cross-functional groups across the Dana-Farber Cancer Institute. The position is focused on providing hands-on expertise to ensure all cleanroom suites are functioning as intended. The selected candidate will be required to work full-time, on-site at the Dana-Farber Longwood location. Located in Boston and the surrounding communities, Dana-Farber Cancer Institute is a leader in life changing breakthroughs in cancer research and patient care. We are united in our mission of conquering cancer, HIV/AIDS and related diseases. We strive to create an inclusive, diverse, and equitable environment where we provide compassionate and comprehensive care to patients of all backgrounds, and design programs to promote public health particularly among high-risk and underserved populations. We conduct groundbreaking research that advances treatment, we educate tomorrow's physician/researchers, and we work with amazing partners, including other Harvard Medical School-affiliated hospitals.
Responsibilities
- Act as the point of contact for CMCF staff and DFCI Facilities staff queries and escalations with regards to any facility issues within the department.
- Perform Preventative Maintenance (PMs) on general lab equipment.
- Perform general repairs that do not require a specialized technician as a biomedical engineer or company specific services.
- Obtain services from outside contractors when repairs require a specialized technician.
- Review and sign-off on PM reports completed by CMCF Biomedical Equipment Technician or outside vendor.
- Monitor facility reports related to HVAC pressure differentials and work with the DFCI Facilities team to resolve any issues.
- Work collaboratively with Facilities to ensure the Building Management Systems (BMS) are executed following GMP principles.
- Work with Facilities to ensure PMs on facility support equipment including but not limited to air compressors, HVAC, RO systems, Oxygen Sensors, Liquid Nitrogen systems are documented according to SOPs.
- Assist CMCF leadership to understand facility systems from a GXP and ISO perspective.
- Collaborate with appropriate parties to ensure maintenance and repairs can be made while minimizing downtime through effective planning and communication.
- Lead any quality investigations and deviations related to the GMP Facility when related to facility or equipment.
- Collaborate with CMCF leadership, quality, vendors and DFCI Facilities to create or improve preventative maintenance tasks or schedules for facility-based equipment.
- Participate in audits when questions arise related to the facility and equipment.
- Oversee the specialized environmental monitoring in the ISO-5/7/8 cleanroom environments.
- Work with Business Director for budgeting purposes to plan for future new or replacement equipment as well as facility repairs or renovations that may be needed.
- Write, review and approve Standard Operating Procedures related to facility and equipment.
- Write, perform and execute validations as needed.
- Continuously review PM forms to insure in line with vendor and regulatory requirements and update accordingly.
- Perform or Coordinate the Installation Qualification, Operation Qualification and Performance Qualification of equipment.
- Represent CMCF in the build out and redesign of systems and space.
- Attend DFCI project meetings as needed to assure compliance with drawings and to expedite field changes where appropriate.
- Revise and establish preventative maintenance procedures to improve equipment performance and Joint Commission compliance.
Requirements
- Bachelors degree in Biomedical Engineering.
- 7 years of equipment maintenance experience with a minimum of 3 years in a laboratory setting.
- GMP experience preferred.
Nice-to-haves
- In depth knowledge of Critical Utility Systems in the life science industry including but not limited to HVAC, Gases, Liquid Nitrogen, Water Systems, etc. as well as building management systems.
- Safety - Knowledge of relevant equipment, policies, procedures, and strategies to promote effective infection control and environmental health and safety.
- Decision Making - Consider the relative costs and benefits of potential actions to choose the most appropriate one. Use logic and reasoning to identify the strengths and weaknesses of alternative solutions.
- Knowledgeable about GXP requirements.
