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Amgen

Sr Engineer I- Instrumentation

Location
Holly Springs, NC (NC)
Posted
Posted today (employer shows the date only)
Source
Workday (employer's applicant tracking system)
Category
Engineering/Technology
Industry
Pharma/Biotech
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Career Category

Engineering

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. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat heart disease, obesity and obesity-related conditions, rare diseases, inflammatory conditions and cancer. 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 INSTRUMENTATION ENGINEER / SYSTEM OWNER- RELIABILITY / INSTRUMENTATION / CONTROLS

What you will do

Let’s do this. Let’s change the world. In this vital role you will be joining the Facilities & Engineering (F&E) group to partner closely with the corporate engineering team to design, build, commission, and qualify new equipment and systems needed for drug substance production. Additionally, you will develop subject matter expertise to support operations upon start up.

  • Provide system ownership for Instrumentation and Control of equipment, and supporting operations at the site, including manufacturing and lab equipment.
  • Provide engineering support for design, construction, startup, commissioning and qualification of instrumentation and controls for new or modified systems.
  • Lead or work with teams in design, development and selection of new systems, instruments, calibration capabilities and consumable items.
  • Partner with Automation Engineers, equipment System Owners and maintenance technicians in identifying and solving field communication issues.
  • Evaluate capabilities of current and potential suppliers, and assess new technologies that could provide cost savings, efficiency, or other unique capabilities to Amgen manufacturing.
  • Identify, support, and/or lead implementation of engineering-based improvements or upgrades in small to medium scope and complexity to the Instrumentation and Controls or facility systems. Lead the development of a case if required to support the completion of the project.
  • Support development of Calibration programs, ensure the availability of spare parts, and coordinate maintenance plan as vital to ensure systems are in accurate working order.
  • Ensure systems are installed and operating safely and align with pertinent environmental health/safety practice, rules and regulations.
  • Ensure vital commissioning and qualification of systems is completed in alignment with site GMP requirements and interact with regulatory inspectors as vital.
  • Apply basic engineering principles and practices in support of daily operation, maintenance, and troubleshooting of plant and process instrumentation systems.
  • Monitor systems to identify performance risks and implement risk reduction strategies.
  • Providing troubleshooting support to reduce production downtime. This will involve leading and/or supporting technical root cause analysis and implementation of corrective/preventive action. (Support may be required outside of normal working hours including nights, weekends and holidays)
  • Support new product/technology introductions by performing engineering assessments, implementing equipment modifications, and supporting engineering runs.
  • Advance the use of condition based and predictive maintenance practices by incorporating sophisticated data analytics where applicable.
  • Own investigations of abnormal conditions through Deviation and business processes.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The engineering professional we seek is a dynamic, flexible, and driven individual with these qualifications.

Basic Qualifications:

  • High school diploma / GED and 10 years of Engineering/I&C experience
  • Associate’s degree and 8 years of Engineering/I&C experience
  • Bachelor’s degree and 4 years of Engineering/I&C experience
  • Master’s degree and 2 years of Engineering/I&C experience
  • Doctorate degree

Preferred Qualifications:

  • A bachelor’s degree in Chemical, Mechanical, or Electrical Engineering.
  • 4+ years' of relevant work experience with 2+ years' experience in Biopharmaceutical operations/manufacturing environment.
  • Hands on experience of design and troubleshooting instrumentation and controls for process equipment and utility systems in a GMP Biopharmaceutical Production facility.
  • Experience with field wiring and communications of field equipment and in relation with process control system such as DeltaV, Allen Bradley PLC and/or Building Automation Systems.

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