Senior Instrument Technician

Amgen•Holly Springs, NC

12d

About The Position

Amgen is hiring a Senior Instrument Technician for its FleX Batch drug substance manufacturing facility. The role provides technical expertise and guidance during plant start-up and daily operations, supporting the Capital Project Delivery team with commissioning and qualification of equipment and systems used in manufacturing, laboratories, utilities, and other site areas. The technician will support implementation of a Metrology program that meets GMP, safety, regulatory, and Amgen Maintenance Excellence requirements, including developing and implementing program documentation. After construction, the technician will work in the Facilities & Engineering team under limited supervision. The position performs and documents calibration, repair, installation, and troubleshooting of instruments used on process control and building systems. Work must be completed safely, compliantly, and on schedule, with minimal production impact and in accordance with GMPs, SOPs, Amgen policies, and regulations. The role also reviews and technically approves maintenance records, supports continuous improvement and team development, communicates with operators and stakeholders, and provides facility and manufacturing support through an on-call rotation that may include nights, weekends, and holidays.

Requirements

High school diploma or GED and 2 years of instrumentation experience, or an associate’s degree and 6 months of instrumentation experience.
Experience in instrumentation maintenance, with emphasis on sanitary processing equipment and systems.
Ability to troubleshoot circuitry up to 480V.
Knowledge of pneumatic, mechanical, and hydraulic systems and ability to perform related instrumentation activities; the posting specifies 5+ years of this knowledge and ability.
Knowledge and experience working in a highly regulated function such as cGMP.
Ability to interpret P&IDs.
Ability to work with minimum direction.
Ability to communicate task issues and status in a timely manner.
Ability to interact constructively with peers and teams.

Nice To Haves

High school diploma or GED and 6 years of instrumentation experience, or an associate’s degree and 4 years of instrumentation experience.
Biotech experience.
Experience executing and documenting maintenance work orders in a computerized maintenance management system, preferably Maximo.

Responsibilities

Support start-up, commissioning, and qualification of equipment and systems across manufacturing, laboratories, utilities, and other site areas.
Support implementation of the Metrology program in accordance with GMPs, safety requirements, local and global regulations, and Amgen Maintenance Excellence standards.
Support development, writing, and implementation of Metrology documentation, including SOPs, change controls, non-conformances, work orders, job plans, hazard risk assessments, and job hazard assessments.
Help ensure the safety of staff during plant construction, start-up operations, and metrology activities.
Calibrate, repair, install, and troubleshoot instruments used on process control systems and building systems, and maintain associated documentation and logs.
Complete quality and safety documentation and perform work safely, compliantly, and on time according to plans and schedules, minimizing production impact.
Work efficiently to maximize completed maintenance activities while focusing on maintenance excellence.
Communicate work appropriately to system operators and key stakeholders.
Accurately complete work order documentation.
Review and technically approve maintenance reports, forms, plans, and records.
Identify waste, workflow interruptions, and improvement opportunities; recommend solutions and assist with implementation.
Identify learning opportunities and participate in development to improve team performance.
Represent the instrumentation team in discussions and meetings with peers and other site functions.
Provide facility and manufacturing support through an on-call rotation, potentially outside normal working hours, including nights, weekends, and holidays.