Sr. Associate Technical Engineer- Night Shift

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 lie within them, you'll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Let's do this. Let's change the world. In this vital role you will provide technical mechanical and electrical engineering support on all system/equipment optimization strategies, upgrades, replacements, repairs, and modifications. You will evaluate and determine if process equipment maintenance, and technical cleaning systems are maintained in compliance with all applicable industry standards, regulatory standards and FDA standards in the Inspection and Packaging area.

• Take part in the coordination of tech support on engineering, regulatory, compliance, quality, technical cleaning, validation, and mechanical/electrical equipment issues.
• Assist during regulatory agency inspections. Provide technical support in response to the FDA and other regulatory agencies.
• Assist in planning, scheduling, and coordinating maintenance activities.
• Complete advanced maintenance activities or operate and monitor sophisticated plant support equipment in accordance with CFRs, cGMPs, SOPs, job plans and Amgen policies.
• Investigate complex issues or problems.
• Assist with maintaining an up‑to‑date working spare parts inventory system for the equipment/systems.
• Create maintenance procedures and assist in changes to optimize the maintenance program, troubleshoot and repair equipment/system failures.
• Develop technical guides and trainings for repetitive tasks.
• Provide training to others for continuous team development.
• Be the point of contact for the lead team of technicians on mechanical and electrical breakdowns.
• Identify improvement opportunities and lead small projects.
• Assist plant engineering in the evaluation and implementation of engineering improvements, policy changes, compliance improvements and optimization programs.
• Interpret and review utility, process system/equipment, plumbing, ductwork plans, architectural, and P IDs.

We are all different, yet we all use our unique contributions to serve patients. The professional we seek will possess these qualifications.

Masters degree

OR

Bachelors degree and 2 years of Technical Engineering experience

OR

Associates degree and 6 years of Technical Engineering experience

OR

High school diploma / GED and 8 years of Technical Engineering experience

Educational background in Mechanical Engineering, Mechatronics, or related technical degree

Experience repairing mechanical equipment in a manufacturing environment (experience with packaging equipment preferred)

Experience working in a regulated industry (ideally GMP, Pharmaceutical)

Knowledge of Reliability Maintenance and Process Optimization

Knowledge in continuous improvement tools and methodologies

Familiar with Computer Maintenance Management Software (preferably Maximo
7)

Strong mechanical aptitude and troubleshooting skills

Understanding in PLC, Computer Serialization, Packaging Equipment, Vision Inspection System (Cognex Vision System and Systech Serialization)

Excellent organizational, project management, problem solving and technical writing capability

Strong…