Direct Report To:
VP Operations and Engineering
The Associate Director, Facilities is a hands-on position responsible for scheduling, troubleshooting and controlling facility engineering/maintenance functions, in a GMP environment, to obtain optimum efficiencies from the equipment, utilities and overall facilities. This role will perform engineering activities required to analyze, implement and coordinate preventative and adhoc maintenance activities. The individual will have the responsibility to oversee and execute projects and regular activities associated with our Biotech facilities, and will be a leader in continuous improvement activities throughout all facilities. Responsible for the implementation of EH&S initiatives, safe working practices, inspections and EH&S training for employees. This includes responsibility for maintaining compliance to local, state and federal environmental, health and safety regulations, including overseeing the site hazardous waste management program.
MAJOR DUTIES AND RESPONSIBILITIES
- The role is responsible for maintaining all equipment, systems, and utilities in support of GMP manufacturing operations and programs.
- Daily responsibilities include:
- status monitoring of the utilities, equipment, cleanroom suites and the overall facilities
- perform reactive and preventive maintenance
- creating/executing work orders related to facilities, systems and equipment
- Data Acquisition System (DAS) alarm response and mitigation
- The incumbent will be responsible for assisting in the creation of programs and procedures, developing operations & monitoring programs, maintaining continual cGMP compliance, maintenance, project and activities supporting operations of process utilities and equipment.
- Develop criteria and performance specifications for equipment / utilities and systems required to meet operating requirements for building and safety codes.
- Develop, implement, monitor and continuously improve systems and programs that cover preventative/corrective/predictive maintenance, with safety and quality integrated into the programs.
- The position will be actively involved in facility design, construction, and renovation activities.
- Provide exceptional customer service and create strong partnerships with internal and external partners such as: Manufacturing, Quality Assurance, Quality Control, Supply Chain, EH&S, Information Technology, Engineering, Calibration and Validation.
- Responsibility for cost management, strategic procurement alignment and budgetary control for services and operations.
- Minimum of 8 years’ experience in a GMP Facilities environment within the biotech or pharmaceutical industries with at least 3 years leading/managing a process maintenance organization.
- Experience in support of aseptic manufacturing facilities, preferred.
- Chemical, Process or Facilities Engineering/maintenance experience is required.
- Client/customer service skills and collaboration with numerous stakeholders is required.
- Experience in startup and commissioning of process utilities and equipment highly desired.
- Experience in design and construction of GMP facilities and working on highly complex projects.
- Advanced understanding of contamination control topics including cleanroom operation, HEPA filtration, disinfection, gowning, and proper material/personnel flow.
- Operations experience in cell therapy/regenerative medicine or biologics.
- Licensed boiler operator (fireman) preferred.
Skills (General Knowledge):
- Motivated leader, who can work independently as well as part of a team, that thoroughly understands the role and the importance of customer service to deliver value to the business.
- Knowledge of aseptic processing regulations, preferably as they apply to commercialized cell therapy and regenerative medicine.
- Experience in current requirements for lifecycle management of GMP assets.
- Understanding of HVAC systems for biotech/pharmaceutical facilities.
- Experience with building automation, monitoring systems, asset management systems and security systems.
- Bachelor’s Degree in engineering (Mechanical, Chemical or other engineering aligned discipline)