SUMMARY With general guidance, provides maintenance leadership, staff supervision, and technical expertise in support of facility equipment/systems, utility systems, and/or production suites, ensures systems operate within designed parameters. Area of responsibility may consist of multiple facilities, disciplines or clients. All work to be completed to assure minimal impact to production while complying with all cGMP guidelines and Amgen procedures. This position will be reporting to an administrative work schedule with the flexibility to support a non-standard shift organization as per business needs. The role is crucial for Amgen's success and will be a key contributor in AML6-Drug Substance department. SPECIFIC RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO: Direct support to Clean / Critical Utilities (WFI, PUR, Clean Steam, HVAC HEPA Systems) to ensure and maximize operational uptime, reliability and compliance to critical parameters. Lead utilities operators and act as utilities system owner. ARMS evaluation and clean utilities related deviations. Support the development of a Maintenance Vision, Mission, Strategies, and Goals that provides a guide to becoming the best maintenance organization. Develop and maintain maintenance metrics to support the benchmarking of site, global, and industry. Develop improvement strategies based off the benchmarking data. Manage the maintenance areas that provides technical, project management, emergency response, trouble shooting and preventative maintenance support for facilities and related equipment. Support consistent global maintenance and operational practices throughout sites. Function as a technical expert to equipment or systems regarding troubleshooting operational issues and point of contact during compliance inspections. Provides solutions to a variety of technical problems. Develop, maintain, and justify the area budgets. Assure the appropriate level of trainings for all levels of the organization such as cGMP's, technical, SOP's, compliance trainings and maintain records for staff. Oversee the development, revision, review, and approval of Standard Operating Procedures/Job Plans that are owned by the area. Support project engineering in the justification, prioritization, and coordination of manufacturing projects. Provide design assistance, as required, using knowledge of both the operations and facilities capabilities and the knowledge of production requirements. Partner with Compliance and Quality Assurance Departments to ensure maintenance operational strategies are in alliance with our compliance commitments. Maintain an environment that promotes maintenance flexibility, consistent maintenance practices, and efficient operations, which prepare us for current and future production demands. EDUCATION/LICENSES Basic Education & Experience Bachelor's degree in Engineering & 5 years of Maintenance, Clean utilities and/or Engineering experience in a GMP environment OR Master's degree in Engineering & 3 years of Maintenance, Clean utilities and/or Engineering experience in a GMP environment OR Doctorate degree in Engineering AND Previous managerial experience directly managing people and/or experience leading teams, projects, programs or directing the allocation of resources PREFERRED QUALIFICATIONS Educational discipline in Biomedical, Mechanical, Chemical and/or Electrical Engineering Clean Utilities (WFI, PUR, Clean Steam, Process Clean Air, HVAC HEPA Systems) industry operational experience Complete knowledge of pharmaceutical/biotech building requirements Familiarity with validation process and cGMP documentation Ability to operate specialized laboratory equipment and computers as appropriate Leadership and team building skills Excellent verbal and oral communication Ability to resolve conflicts Ability to make disciplined decisions Knowledge of staff relations with the ability to coach mentors and counsels' staff when needed Good organizational skills Ability to deal with and manage change Knowledge of basic compensation system practices and methodologies Strong computer knowledge Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. Join Us If you're seeking a career where you can truly make a difference in the lives of others, a career where you can work at the absolute forefront of biotechnology with the top minds in the field, you'll find it at Amgen. Amgen, a biotechnology pioneer, discovers, develops and delivers innovative human therapeutics. Our medicines have helped millions of patients in the fight against cancer, kidney disease, rheumatoid arthritis and other serious illnesses. As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other but compete intensely to win. Together, we live the Amgen values as we continue advancing science to serve patients. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. .
