Senior Sterilization Engineer

Senior Sterilization Engineer page is loaded## Senior Sterilization Engineer remote type:
On Site locations:
US - Massachusetts - Cambridge time type:
Full time posted on:
Posted Todayjob requisition :
R-209200##
** 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.

Senior Sterilization Engineer##
** What you will do
** Let’s do this. Let’s change the world. In this vital role you will work as part of a multi-disciplinary program to build and maintain drug delivery solutions which meet user requirements for Amgen’s portfolio of therapeutic products from concept through commercial production. The individual will be responsible for designing, conducting, and analyzing new process development, validation and requalification studies for gas sterilization modalities for combination products at multiple sterilization processing vendor sites.

This role will serve as sterilization technical lead to support commercial production sterilization processing operations for at least one vendor. The successful candidate will lead collaborations with cross-functional teams to ensure compliance with regulatory standards and industry best practices. This role will also include assessments and approvals of Amgen primary container systems supplier sterilization process validations, requalification and site transfers, as well as performing sterilization standards changes impact assessments for Amgen primary container systems.
* Sterilization Technical Lead for commercial launch and production sterilization processing operations for a novel gas sterilization process for a combination product
* Lead/ support sterilization process deviations impact assessments for routine production
* Lead/ support sterilization process annual reviews and requalifications; bioburden and environmental monitoring activities and Biological Indicator (BI) test report reviews
* Support audit preparation, inspection readiness and onsite audit activities
* Support/ lead process development of gas sterilization processes of combination products
* Coordinate manufacturing site requirements to support sterilization requirements
* Support tech transfer projects for combination products sterilization processes
* Support on-going deviation/ CAPA and change control
* Support/ lead Amgen primary container system supplier sterility assurance assessments for gamma, E-beam, X-Ray, ethylene oxide and steam sterilization modalities; and microbiological evaluations
* Collaborate extensively with internal and external stakeholders i.e. manufacturing, suppliers, quality, regulatory, senior management, etc.
* Drive and influence key opinion leaders by providing technical papers, presentations and attending conferences
* Lead sterilization standards changes impact assessments for Amgen primary container systems
* Lead/ support authorship of regulatory filings and responses to regulatory agency questions
* Provide sterilization training to key internal and external stakeholders##
** 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 an individual with these qualifications.
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* Basic Qualifications:

*** High school diploma / GED and 10 years of Engineering experience;…