Amgen
Holly Springs, NC
Shift: Full time
Career Category Manufacturing Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.
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What you will do Let’s do this. Let’s change the world. In this vital role you will provide technical expertise and guidance supporting the start-up of the plant and daily operations. Responsibilities include: Focus year’s 1 and 2 will be to partner with the Capital Project Delivery and Site Operations team providing technical support associated with the start-up, commissioning, and qualification of the wide variety of equipment and systems used in Manufacturing, Laboratories, Utilities, and other areas at the site. Support development, writing and implementation of the Maintenance program documentation including Standard Operating Procedures (SOP), Work Orders (WO), Job Plans (JP), Hazard Risk Assessments (HRA), Job Hazard Assessments (JHA), etc. Ensure safety of all staff during plant construction and start-up operations and maintenance activities. Post-Construction completion and continued operations: Performing intermediate installation, troubleshooting, maintenance, repair, testing and documentation/logs of process and utility equipment. Completing quality and safety documentation and completing the work in a safe, compliant, and timely manner according to planning and predefined schedules with minimal impact to production while aligning with GMP standards, SOP adherence and Amgen policies and regulations. Able to work in a highly productive and efficient manner to maximize successful outcome to activities completed with a focus on maintenance excellence. Ensure work is appropriately communicated to system operators and key stakeholders. Ensure work order documentation is completed accurately. Identify opportunities to learn new skills and actively participate in the development that will improve overall team performance. Reviewing and technically approving maintenance reports, forms, plans and records. Identify waste, work-flow interrupters, recommend solutions, and assist with implementation. Identify opportunities to learn new skills and actively participate in development that will improve overall team performance. Represent Maintenance team as a leader or as a delegate to the management team in discussions and meetings with peers and other site functions. Provide facility and manufacturing support as needed with on-call rotation - this may be outside of normal working hours including nights, weekends, and holidays. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The resilient professional we seek shall be able to adjust well in a fast pace working environment, while collaborating to solve issues and drive continuous improvements with these qualifications. Basic Qualifications: High school/GED 1 year of Maintenance work or military experience OR Associate’s degree Preferred Qualifications: Knowledge and experience working in a highly regulated function – cGMP. Experience executing and documenting maintenance work orders in a computerized maintenance management system. Ability to interpret P ID s. Ability to effectively communicate issues and status of tasks in a timely manner. Ability to interact constructively with peers. Works well in teams and utilizes science-based collaboration to drive continuous improvements Has an understanding and utilizes World Class Maintenance initiatives to deliver positive outcomes Works effectively with others who have different perspectives, backgrounds and/or styles and can produce positive outcomes without relying on unnecessary oversite. A leader in safety, quality, and compliance. What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every s