Senior Engineer - Manufacturing Systems

Career Category

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.

Senior Engineer - Manufacturing Systems

What you will do

Let’s do this. Let’s change the world. In this role as a member of the Amgen Manufacturing & Clinical Supplies – Facilities & Engineering (MCS-F&E) Automation team you will support Clinical and Commercial Drug Substance plant operations This includes complex and challenging system automation initiatives that require understanding of various automation platforms, integration between multiple platforms, analytical problem-solving techniques, critical thinking, project management, lifecycle management and Operational Excellence.

Responsibilities include:

• Develop and maintain process control automation solutions applying DeltaV Distributed Control System (DCS), Rockwell Programmable Logic Controllers (PLC), Human Machine Interfaces (HMI), Supervisory Control and Data Acquisition systems (SCADA
• Lead/support technical root cause analysis, incident investigations, and trouble shooting on process control issues related to plant operations.
• Own change control records, CAPA records and deviations as it relates to Automation systems.
• Support functional area projects focused on improving process equipment, cleaning systems and utilities to ensure reliability of drug substance manufacturing facility.
• Lead and support new technology introductions by performing automation engineering assessments, implementing automation system configuration changes, and supporting engineering and process qualification runs as applicable.
• Provide Continuous Improvement initiatives including Safety, Reliability, Efficiency and Environmental sustainability improvements to meet Amgen’s Ambitious goals.
• Maintain Data Integrity Assessments with the current Amgen and Industry standards.
• Support Review by Exception (RbE) functionality that includes product Batch records, cleaning, and sterilization systems, Audit trail and version control systems.
• Collaborate with Amgen Drug Substance Plant network to enhance the automation design for Drug Substance Plant Operations
• Be knowledgeable about compliance and regulatory aspects for operation and maintenance, equipment validation, and support regulatory inspections and audits.
• Day-to-day Operational Support including:
• Direct Manufacturing Support required for Critical Operations
• 24 x 7 Onsite/On Call as required.
• Trouble shooting Support to Manufacturing operations, cleaning systems, plant utilities and Building management system
• Automation System Administration
• Automation System Operating Systems (OS) security patching and HotFix assessments and rollout
• Daily manufacturing and engineering work center team meetings
• Preventative and corrective maintenance
• Automation System spare parts management

What we expect of you

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

Basic Qualifications:

Doctorate degree

Or

Master’s degree and 2 years of Manufacturing Automation Engineering experience

Or

Bachelor’s degree and 4 years of Manufacturing Automation Engineering experience

Or

Associate degree and 8 years of Manufacturing Automation Engineering experience

Or

High school diploma / GED and 10 years of Manufacturing Automation Engineering experience

Preferred Qualifications:

• Degree in Electrical Engineering, Chemical Engineering or Biotech
• Extensive understanding and background in programming, design, installation, and lifecycle management of manufacturing process controls, automation, and field instrumentation
• Demonstrated hands-on experience