Director Statistical Programming Jobs in Apex, NC

Position Overview:

Beam is looking for a highly energetic Facilities & Maintenance Associate Director / Director for the further development and on-going operation of the maintenance, calibration, and facilities site programs. The candidate will be responsible for managing maintenance of the building, grounds, utility and production equipment to Beam's NC manufacturing facility. In addition to a strong facilities, maintenance, and reliability background, the ideal candidate should also possess the ability to successfully interface with multidisciplinary teams as well as engage and collaborate with external partners, manufacturing operations, quality and validation, and finance. This position will provide strategic and technical leadership for production and facility maintenance operations while developing work processes, management systems and people to optimize operations.

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. Monitor and control expenses to stay withing budget guidelines
• Collect, analyze and report statistical data from CMMS and elsewhere as may be required to provide accurate and current assessment of facility management objectives
• Develops and drives the risk management programs for the site
• Continue to develop and maintain the spare parts inventory program
• Evaluate, specify and recommend new equipment for the site
• Ensure timely execution of the preventative maintenance and calibration programs
• 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
• Background in cGMP manufacturing/operations knowledge
• Experience developing and managing department budget
• Experience leading and managing 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 (interna/external) and demonstrated collaboration in a team environment
• Results oriented with the ability to demonstrate resiliency, ownership and drive
• Must be willing 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. Facilities and Maintenance team provides 24/7 site coverage.