Sr Associate Mfg - Nights

Career Category Operations 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. Senior Associate Manufacturing - Nights What you will do Let’s do this. Let’s change the world. In this vital role you will perform operations in the Manufacturing area, specifically Inoc/Seeds. Operations will be performed according to Standard Operating Procedures (SOPs). Senior Associate will perform and monitor critical processes, execute routine validation protocols, and regularly draft and revise documents such as Manufacturing Procedures, SOPs, and technical reports. Senior Associate will also perform basic troubleshooting and assist in the review of documentation for assigned functions. May participate on cross-functional teams and represent the Inoc/Seeds group. Senior Associate may also have the responsibility of owning NC/CAPA’s and Change Control records. In addition, Senior Associate may identify, recommend, and implement improvements related to routine function. In this role, you will be expected to work a 12-hour shift (7PM-7AM) on a rotating schedule (D Shift). This includes extra benefits such as  receiving an added 15% shift differential, and also getting premium pay for any Sundays worked.  The schedule during the initial on-boarding phase for this role (2-6 weeks) will be administrative (Monday through Friday, approximately 8am to 5pm).

Lead manufacturing operations on the production floor. Ensure all safety and compliance procedures are followed at all times. Participate in the development, implementation, and issue resolution associated with process equipment Commissioning, Qualification, and Validation. Provide troubleshooting, technical support, and resolution of equipment, automation, and process issues on the manufacturing floor. Write, revise, and own controlled documentation (SOPs, Manufacturing Procedures (MPs), Forms, Technical Reports, etc.) Serve as SME for functional area operations. Provide training to manufacturing staff on process and equipment. Own deviations and Corrective and Preventive Actions (CAPA) Champion Lean Transformation and OE initiatives; facilitate the drive towards continuous improvement in all Manufacturing areas. Collaborate with Quality, Engineering, Process Development, Validation, and Operations to resolve manufacturing events in a timely manner. Assure appropriate escalation to different levels of management when personnel and environmental safety, equipment functionality, product supply, or quality are at risk. Collaborate with Quality, Manufacturing Managers, Plant Engineering, Process Development, and Regulatory Compliance staff in multi-functional teams. Participate in the design, development, and implementation of processes in support of the manufacturing floor. What we expect of you We are all different, yet we all use our unique contributions to serve patients. The dedicated