Senior Instrument Technician

Amgen•Holly Springs, NC

About The Position

Senior Instrument Technician Career Category Maintenance 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. 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. Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027. Senior Instrumentation Technician 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. During Construction Phase: The initial focus of this role for the majority of 2024 will be to work closely with the Capital Project Delivery 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 the implementation of the Metrology program meeting all Good Manufacturing Practices (GMPs) and safety requirements, local/ global regulations, and Amgen Maintenance excellence standards. Support the development, writing and implementation of the Metrology program documentation including Standard Operating Procedures (SOP), Change Control (CCMS), Non-Conformance (NC), 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 metrology activities. Post-Construction completion and continued operations. In this key role within the Facilities & Engineering team, under limited supervision, the Senior Instrument Technician is responsible for: Performing calibration, repair, installation, troubleshooting and documentation / logs of instruments used on process control systems and building systems. 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 GMPs, SOPs and Amgen policies and regulations. Work in a highly productive and efficient manner to maximize the quantity of activities completed with focus on maintenance excellence. Ensure work is appropriately communicated to system operators and key stakeholders. Ensure work order documentation is completed accurately. Reviewing and technically approving maintenance reports, forms, plans and records. Identify waste, work-flow interrupters, and other opportunities for improvement, 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 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.

Requirements

High school diploma / GED and 6 years of Maintenance experience OR Associate’s degree and 4 years of Maintenance experience

Nice To Haves

Experience in mechanical maintenance with an emphasis on sanitary processing equipment and systems.
3+ years knowledge of pneumatic, mechanical, and hydraulic systems and ability to effectively perform associated maintenance activities.
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 work with minimum direction.
Ability to effectively communicate issues and status of tasks in a timely manner.
Ability to interact constructively with peers/teams.

Responsibilities

Provide technical expertise and guidance supporting the start-up of the plant and daily operations.
Work closely with the Capital Project Delivery 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 the implementation of the Metrology program meeting all Good Manufacturing Practices (GMPs) and safety requirements, local/ global regulations, and Amgen Maintenance excellence standards.
Support the development, writing and implementation of the Metrology program documentation including Standard Operating Procedures (SOP), Change Control (CCMS), Non-Conformance (NC), 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 metrology activities.
Performing calibration, repair, installation, troubleshooting and documentation / logs of instruments used on process control systems and building systems.
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 GMPs, SOPs and Amgen policies and regulations.
Work in a highly productive and efficient manner to maximize the quantity of activities completed with focus on maintenance excellence.
Ensure work is appropriately communicated to system operators and key stakeholders.
Ensure work order documentation is completed accurately.
Reviewing and technically approving maintenance reports, forms, plans and records.
Identify waste, work-flow interrupters, and other opportunities for improvement, 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 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.