Associate Director / Director, Facilities & Maintenance
Beam Therapeutics · Durham, NC · Yesterday
On-siteManufacturingFull-time
Responsibilities
- Responsible for the facilities and maintenance team activities
- Coordinate and schedule work based on priorities and ensure all documentation is compliant with GxP practices
- Responsible for all site facilities, engineering, and maintenance contract agreements and relationships
- Develop and maintain Standard Operating Procedures for the facilities and CMMS system
- Responsible for routine shutdown coordination and planning
- Work as a liaison between Engineering, Maintenance, Production and other Site Business Partners
- Responsible for maintenance schedule based on work order due dates, equipment and technician availability, planning progress and vendor availability, where necessary
- Manage facilities vendors, including janitorial and HVAC, electrical, and plumbing contractors
- Work with third-party vendors for repairs, maintenance, and service contracts, ensuring timely and cost-effective solutions
- Collaborate with the property manager/landlord on matters related to the building lease and services as required
- Ensure compliant operations in accordance with site registrations, cGMP, environmental regulations and federal/state requirements
- Support CAPA, Change Control, Deviation, Risk Analysis, Root Cause Analysis, and other Quality Systems
- Direct support of FDA/EMA and internal audits
- Manage, develop and maintain all space planning requirements, including internal employee moves, new hires and floor plans
- Manage the facilities budget, ensuring cost-effective spending on repairs, maintenance, and capital improvements
- Maintain and refine the standard operating procedures and work instructions for the department
- Ensure organizational structure, technical capability, resources and processes exist to achieve the current and future objectives for the operation
- Cultivate Beam’s culture and values-driven organization focused on its people
- Proactively analyze production and facility issues and coordinate potential resolutions with the team
- Provide technical and personal development mentoring for maintenance personnel
Qualifications
- BS degree in a technical discipline (Engineering preferred)
- 10+ years’ experience leading maintenance personnel within a biotechnology/pharmaceutical/medical device manufacturing environment
- In depth knowledge and understanding of equipment including utility systems, production equipment and lab equipment
- Experience developing and managing a CMMS program
- Excellent verbal and written communication skills
- Dynamic interpersonal skills, including demonstrated ability to manage through influence
- In depth knowledge and understanding of cGMP manufacturing/operations knowledge
- Experience developing and managing department budget
- Ability to lead and manage a team
- Ability to work on multiple projects and manage various priorities and timelines and to adapt quickly to changing circumstances
- High degree of customer focus (internal/external) and demonstrated collaboration in a team environment
- Results oriented with the ability to demonstrate resiliency, ownership and drive
- Willingness to have a flexible schedule during process start up and manufacturing runs, which may include supporting critical operations outside of normal work hours, as needed.