Manufacturing Systems Engineer - AML 6 Drug Substance

Posted:
8/20/2024, 5:00:00 PM

Location(s):
Puerto Rico, United States ⋅ Juncos, Puerto Rico, United States

Experience Level(s):
Junior ⋅ Mid Level ⋅ Senior

Field(s):
IT & Security

Workplace Type:
Remote

Career Category

Engineering

Job Description

HOW MIGHT YOU DEFY IMAGINATION?

You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Manufacturing Systems Engineer – AML 6 Drug Substance

Live

What you will do

Let’s do this. Let’s change the world. In this vital role you will provide process optimization strategies and troubleshooting of issues in the manufacturing, and/or capital projects environment in the second and third shift operations. As part of a non-standard rotating shift, the team focuses in apply basic engineering principles to the design and implementation of system modifications, tests and/or capital projects. Organizes, analyzes and presents interpretation of results for operational issues and/or low complexity engineering projects. This role supports a Non-Standard shift structure that may include extended hours, nights, weekends and holidays.

Specific responsibilities include but are not limited to:

  • Provide solutions to a variety of technical problems of moderate scope and complexity.
  • Under general supervision will evaluate, select and apply standard engineering techniques and procedures.
  • Perform assignments that have clear and specific objectives and require investigation of limited number of variables.
  • Initiate and complete routine technical tasks.
  • Timely and regular attendance to workplace.
  • Trace and resolve equipment, system, automation or process issues.
  • Function as a technical expert to automation systems regarding troubleshooting operations.
  • Frequently become actively involved in daily operations when required to meet schedules or to resolve problems.
  • Routinely audit the operational performance and regulatory compliance of a moderate number of equipment items or systems.
  • Work with Manufacturing, Maintenance, Process Development, Utilities, Facilities, Quality Assurance and/or Validation departments in developing requirements and recommendations for system modifications.
  • Obtain quotes for equipment modifications or installations.
  • Develop process control applications using Programmable Logic Controllers (PLC), Distributed Control Systems, Human Machine Interfaces (HMI) and Supervisory Control and Data Acquisition systems (SCADA).
  • Develop expertise with industry standards for batch control systems, software development process methodologies, 21 CFR Part 11, and GAMP.

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Manufacturing Systems Engineer professional we seek is an individual contributor with these qualifications.

Basic Qualifications:

Master’s degree in Engineering

OR

Bachelor’s degree in Engineering and 2 years of Engineering and/or Automation experience.

Preferred Qualifications:

  • Educational background in Computer Engineering or Electrical Engineering, and two (2) years of experience.
  • Background in programming, design, installation and lifecycle management of manufacturing process controls, automation, and Batch Control System
  • Knowledge and Experience working in GMP environment with pharmaceutical/biotech processes
  • Experience in programming, design, installation and lifecycle management of manufacturing process controls, automation and field instrumentation technologies.
  • Knowledge and experience working with computer validation processes and documentation, including validation protocol writing
  • Knowledge on Rockwell Automation Platform (SLC500) and Allen-Bradley PLCs
  • Knowledge in Factory Talk, FTView SE,  FTBatch system and ControlLogix PLC Platform.
  • Work schedule flexibility to support 24/7 operations
  • Knowledge in programming language (e.g. VBA) and DeviceNet technologies
  • Strong communication skills in English and Spanish (verbal and writing skills)
  • Good problem solving, technical report writing, presentation, organization, and applied engineering skills
  • Computer Literacy (MS Office Suite, SharePoint, Spotfire, etc.)

Thrive

What you can expect of us

As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.

In addition to the base salary, Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:

  • Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance
  • A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
  • Stock-based long-term incentives
  • Award-winning time-off plans and an annual site shutdown
  • Flexible work models, including remote work arrangements, where possible

Apply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.

careers.amgen.com

Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

.