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Amgen

Makes biotech medicines for serious illnesses

Manufacturing Systems Engineer - DeltaV

Controls & Automation EngineeringConfirmed live in the last 24 hours
Full-timeWest Greenwich, RI, USAIn-person

About the Job

Requirements

  • High school diploma or GED and 8 years of automation and/or engineering experience, or an associate’s degree and 6 years of automation and/or engineering experience, or a bachelor’s degree and 2 years of automation and/or engineering experience, or a master’s degree.
  • Three or more years of process automation engineering experience in a manufacturing support environment, including at least one year in the pharmaceutical or biotechnology industries.
  • Three or more combined years of experience with Emerson DeltaV distributed control systems.
  • Familiarity with batch control system industry standards, software development life cycle methodologies, S88, 21 CFR Part 11, validation, and GAMP.
  • A strong control system automation background, including design, installation, programming, and validation of automated processes.
  • Experience with mammalian cell culture, protein purification, clean utilities, CIP, SIP, production services, and non-GMP utilities.
  • Experience with tech transfer, process design, and commissioning.
  • Experience with validation and change control methodology.

Responsibilities

  • Provide technical support to commercial manufacturing in process control, automation infrastructure, and process systems.
  • Work with manufacturing, process engineering, utility operations, maintenance, quality assurance, and validation teams to manage a diverse portfolio of projects.
  • Lead and support technical root cause analysis, incident investigations, and troubleshooting of process control issues involving electrical, instrumentation, and control systems, primarily DeltaV.
  • Support new product and technology introductions by performing engineering assessments, implementing automation system configuration changes, and supporting engineering runs.
  • Develop new approaches to complex problems by adapting and modifying standard automation technical principles.
  • Develop, organize, analyze, and present results for operational issues and engineering projects of small scope and complexity.
  • Communicate with multiple organizational levels, highlighting issues and proposing solutions.
  • Support capital project design review, commissioning, and qualification.
  • Apply automation engineering principles to the design, specification, construction, startup, and validation of process and GMP utilities equipment and systems for projects of significant scope and complexity.
  • Provide 24x7 on-call technical support and issue resolution for Automation systems on a rotational basis.
  • Apply experience and knowledge of industry best practices and tools to support an innovative organization.

Desired Qualifications

  • A bachelor’s degree in a related technical field.

About the Company

Amgen

Makes biotech medicines for serious illnesses

Amgen develops and makes biologic medicines, which are drugs built from proteins and antibodies grown in living cells, for serious conditions such as heart disease, cancer, and bone loss. Its anemia drug Epogen, approved in 1989, became one of the biotechnology industry's first blockbuster medicines. Amgen grows these drugs in large tanks called bioreactors, and its products include the cholesterol drug Repatha, the bone-building drug Evenity, and the severe asthma drug Tezspire. It earns money by selling these medicines, mostly through large drug wholesalers that supply hospitals and pharmacies. Amgen was founded in 1980 and is based in Thousand Oaks, California.

Company size
10,001+
Company stage
IPO
Headquarters
Thousand Oaks, CA
Founded
1980

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