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You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role. Amgen, one of the world’s leading biotechnology companies is investing $550 million to build a new multi-product drug substance biomanufacturing facility in Holly Springs, North Carolina, a biomanufacturing 'hub' known for their life sciences industry. The new plant will combine two production formats, traditional stainless steel-fed batch and single use technology. This combination of capabilities is an approach that Amgen calls 'FleX Batch' manufacturing, which makes the facility more dynamic and efficient, as well as requiring a smaller physical footprint than a traditional plant. Additionally, the plant will integrate innovations to advance digitalization and sustainability, aspiring to embed industry 4.0 capabilities and reduce energy consumption and waste generation to meet Amgen’s plan to be carbon neutral by 2027.
Job Responsibility
Provide technical and administrative leadership to a large and diverse group of craft-oriented personnel, including utility operators, electricians, and HVAC maintenance technicians
During construction phase: Support the start-up of all site utility systems and transfer of ownership to the F&E utilities team
Develop and implement a long-term strategy for leading continuous plant and clean utility operations and maintenance of installed systems and equipment including system setups in Maximo etc
Support the development and implementation of goals and objectives and associated budgets for all utility services and equipment including but not limited to site utility accounts and maintenance programs
Ensure utility operations and maintenance programs are aligned with cGMP and safety requirements, local/global regulations, and Amgen Maintenance excellence standards
Institute supporting organization and business structures, including innovation and talent development
Ensure that procedures are in place for cGMP and daily activities and are followed by area personnel and contractors
Ensure safety of all personnel during plant construction and start-up operations and maintenance activities across multiple shifts providing 24/7 plant and utility coverage
Post-Construction completion and continued operations: Responsible for leading the Amgen NC F&E utility staff and Service Providers supporting continuous clean and plant utility operations including electrical and HVAC systems at the site
Provide support as required, including outside of normal working hours to maintain continuous and compliant utility operations at the site
Management and monitoring of a robust utility system maintenance program consisting of preventive, predictive, and corrective maintenance activities to improve personnel safety, equipment reliability, overall equipment efficiency, and product quality
Ensure that all staff are trained and follow all safety and GMP standards and procedures
Improve staff productivity and the efficient use of available resources across facilities
Analysis and accurate review of engineering/ construction/ maintenance cost forecasts against scope
Oversight and execution of sophisticated facilities/utilities/maintenance related initiatives and small projects
Provide expertise and resources for capital project execution
Work cross-functionally with individuals, partners, clients, and others in Engineering, Environmental Health & Safety, Quality, Supply Chain and Manufacturing networks
Maintain and improve plant capability and equipment reliability in partnership with engineering leadership and technical staff
Identify areas of potential improvement, conduct analyses, recommend solutions, sponsor improvement projects and lead or support implementation
Maintain and develop key performance indicators of maintenance performance, lead, assess, develop staff and ensure that all targets and achievements are completed on time and on budget
Support network-wide improvement in plant maintenance and operation
Provide leadership and guidance to organizational resources to accomplish activities and objectives
Build a culture that cultivates and rewards creativity and innovation
Requirements
High school diploma / GED and 10 years of Manufacturing Equipment Maintenance experience
Associate’s degree and 8 years of Manufacturing Equipment Maintenance experience
Bachelor’s degree and 4 years of Manufacturing Equipment Maintenance experience
Master’s degree and 2 years of Manufacturing Equipment Maintenance experience
Doctorate degree
In addition to meeting at least one of the above requirements, you must have experience directly managing people and/or leadership experience leading teams, projects, programs, or directing the allocation or resources.
Nice to have
2 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
4+ years’ experience in engineering or utility operations within biotechnology and/or pharmaceutical or other regulatory environments, or Military experience
3+ years’ experience of ensuring compliance in a highly regulated environment
Demonstrated interpersonal and facilitation skills and ability to work in a collaborative team-based environment
Ability to apply analytical skills to evaluate and interpret complex problems using multiple sources of information
Ability to lead multiple tasks and effectively set priorities
Demonstrated ability in goal setting and driving continuous improvement through setting and monitoring of key metrics
Extensive knowledge of electro-mechanical, fluid, and gas equipment and systems
Solid understanding of maintenance management, utilities operations programs, and Computerized Maintenance Management Systems
Demonstrated skill in analyzing and improving facilities related quality systems