Director, Facilities (BSS) & Engineering
BioNTech
- Gaithersburg, MD
- Permanent
- Full-time
- Provide oversight to the Facility Maintenance, Calibration, Capital Expense, Validation, Automation, and Security programs for the assigned site
- Responsible for leading the development of the utility and equipment risk framework and process for the site
- Responsible for delivering end to end maintenance and calibration process improvements as well as leading the organization in identification and implementation of a world class maintenance program
- Collaborates with Manufacturing and Quality teams to ensure equipment and facility remains available for use and does not impact the ability to deliver projects and products
- Assumes overall accountability for the management of building, equipment, and grounds
- Responsible to maintain and support continuity of GMP manufacturing operations in a reliable, efficient and compliant manner.
- Responsible for site facility business continuity and critical systems redundancy, 24/7 support model and site resiliency/recovery plan
- Accountable for site capex portfolio management and successful capex project delivery
- Accountable for developing and delivering the Gaithersburg Site sustainability roadmap
- Administer the organization that will manage the maintenance of the manufacturing envelope as well as the uptime of the critical manufacturing and QC equipment
- Accountable for staff development, budgeting and cost control, talent mapping, succession planning, the development of strong leaders within the function, and multifunction long-term planning
- Coordinate the activities of department management and provide direction and assistance on resolution of complex issues, compliance issues and potential problems related to production planning and material management
- Provides compliance with respect to scheduled Planned Maintenance and calibrations
- Ensures Computerized Maintenance Management System remains current
- Maintain relevant files, drawings, and records required for a GMP operation
- Manage capital and non-capital projects to improve capacity, quality, efficiency, utilization and EHS
- Responsible for capital plan and forecasting as well as departmental budget
- Responsible for projects to maximize output, minimize cost and support efficiencies and improve EHS performance
- Maintain collaboration with Corporate Facilities and Engineering as well as the global and regional F&E networks
- Evaluates the best practices amongst the internal network and external resources
- Consults and cooperate with site/ business unit / corporate / supplier personnel as
- authorized and required, maintaining effective communications, and working relations
- Ensures a relevant knowledge base in place to best manage programs with respect to governing cGMP regulations, requirements of city, state and federal permitting and environmental agencies as it relates to the business
- Serves as a member of the Site Leadership Team and demonstrate ownership of the business unit goals and objectives.
- BS degree in Engineering and minimum of 12+ years of relevant experience in cGMP manufacturing, facility maintenance experience in the biotechnology or pharmaceutical industry and/or prior industrial maintenance experience involving mechanical, electrical and electronics in a cGMP regulated environment
- We will ask you to develop solutions to highly complex problems which require an in-depth degree of ingenuity, creativity, and innovation
- Proven experience with site capital portfolio management and capital project delivery
- Enterprise leadership and strategic mindset within function and at a global/business level
- Excellent and effective global stakeholder management experience
- Demonstrates the ability to deal across several multi-national agencies, sites, and organizations
- Strong computer and organizational skills required. Project management experience required.
- Experience and knowledge on GMPs and supporting GMP manufacturing operations
- Working knowledge of automation control, alert and data collection/retention systems
- Working knowledge of HVAC and clean utility systems