Engineer, Manufacturing Engineer

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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. 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.
** Engineer
* *** What you will do
** Let’s do this. Let’s change the world.

As a member of the Amgen Manufacturing & Clinical Supplies – Facilities & Engineering (MCS-F&E) Analytical Engineering team you will support Clinical and Commercial Drug Substance plant operations.  This role provides system owner oversight and lifecycle management of a wide range of devices in multiple production areas such as cell counters, metabolite analyzers, blood gas analyzers, osmometers, spectrophotometers, endotoxin analyzers, TOC analyzers, and filter integrity testers.  

The successful candidate will work cross functionally to ensure uptime of equipment, improve reliability, coordinate troubleshooting activities with the team and vendor, manage preventative maintenance, spare parts, SOPs, and forms, and help drive continuous improvement activities.
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* Role Responsibilities:

*** Serve as team lead working with individuals and teams in Analytical, Engineering, Instrumentation, and Manufacturing to support plant operations.
* Lead/support technical root cause analysis, incident investigations, and troubleshooting on a diverse portfolio of analytical systems
* Perform job plan and preventative maintenance schedule optimization to reduce labor hours required to maintain instruments
* Own change control records, CAPA records and deviations as it relates to analytical systems
* Coordinate offsite vendor support and maintenance of equipment service contracts
* Lead and support new technology introduction and lifecycle replacements of aging equipment by ensuing qualification requirements are met
* Provide Continuous Improvement initiatives to mitigate potential failures and reduce production delay hours
* Maintain Data Integrity Assessments with the current Amgen and Industry standards.
* Support staff proficiency by training team members and standardizing best practices
* Collaborate with Amgen Drug Substance Plant network to enhance knowledge base and identify improvements for implementation at ATO
* Draft and revise standard operating procedures, forms, and reports
* Manage spart parts inventory and strategy for level 1, GMP equipment
* 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 for analytical instruments in multiple DS plants  + Analytical Equipment Administration  + Daily manufacturing and engineering work center team meetings  + Preventative and corrective maintenance  + Spare parts management
** What we expect of you
** We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek is an individual with these qualifications.
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* Basic Qualifications:

*** High school diploma / GED and 8 years of Engineering or Operations experience OR
* Associate’s degree and 6 years of Engineering or Operations experience OR
* Bachelor’s degree and 2 years of Engineering or Operations experience OR
* Master’s degree
** What you can…