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Engineer - Physical Methods

3 months ago

Cambridge, United States Amgen Full time

HOW MIGHT YOU DEFY IMAGINATION?

Youve 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 missionto serve patientsdrives all that we do. It is key to our becoming one of the worlds leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.

Engineer - Physical MethodsLive

What you will do

Lets do this. Lets change the world. In this vital role you will be responsible for engineering activities required for the development / qualification / validation and transfer of physical GMP test methods for combination products, devices, primary containers, and secondary packaging components. The Engineer shall have the ability to work on multiple projects at one time that may involve changes or new product, processes, tooling or equipment introduction to improve quality and reliability and reduce cost. Phases of projects include: developing combination product test methods, providing key expert support for qualification, validation, transfer, and life cycle support of methods for manufacturing, new product introduction, training, and production support.

  • Develop, qualify, and validate GMP physical test methods for vials, prefilled syringes, and injection devices.
  • Work in teams to transfer new combination product test method and assembly requirements to manufacturing, by developing six sigma processes and compiling documentation for manufacturing assembly requirements.
  • Develop, qualify, validate, and transfer new equipment, software, systems, and methods.
  • Implement projects per Final Product Technologies and company procedures to ensure projects are completed on schedule and within established budget.
  • Provide expert support for investigations as well as new process development required to improve manufacturing operations.
  • Coordinate test method development and delivery with selected contractors.
  • Ensure that qualification parameters are met for product assembly requirements.
  • Support development of cost estimates for new processes, gauges and equipment development used in generation of capital request documentation.
  • Generate procedures necessary to support department and new process equipment.
  • Provide expert training to individuals in the operation and maintenance of processes, test methods and equipment introduced to Quality Control and/or the manufacturing department (i.e. production operator, mechanics, process engineers).
  • Participate in and assume responsibilities of team functions as assigned (i.e. Product Improvement Teams).
  • Generate/author and own the Test Method documents.
  • Gather test method requirements that result in equipment that operates safely and considers ergonomic factors in the design
  • Perform other duties as required by the Group Manager
  • Follow the requirements, responsibilities, and authority as required
  • Maintains integrated timelines capturing appropriate cross functional details and deliverables which are aligned with the functional and project deliverables
  • Networks internally to ensure alignment, commitment to project objectives and timelines as well as to ensure effective execution of projects
  • Networks with manufacturing, quality and regulatory organizations both internal and external to Amgen
  • Drives the cross-functional communication and integration of information to optimize decision making, issue resolution and change management throughout project lifecycle
  • Excellent verbal and written communication skills are applied to communicate project status and risks associated with integrated timelines to leadership
  • Collaborates with other functional leaders to ensure project success, momentum and commitment
  • Proactively identifies issues and/or risks and develops mitigation options to resolve or escalate efficiently
  • Integrates partner/vendor timelines with Amgen timelines as appropriate
  • Assist with CAPAs and change controls for the continuous improvement and lifecycle management of production transferred methods

    The position will require approximately 10% travel to international locations assisting our development partners during implementation of container closure integrity methods into their processes.Win

    What we expect of you

    We are all different, yet we all use our unique contributions to serve patients. The experienced professional we seek is an Engineer with these qualifications.Basic Qualifications:

    High school diploma / GED and 8 years of engineering/scientific experienceOr

    Associates degree and 6 years of engineering/scientific experienceOr

    Bachelors degree and 2 years of engineering/scientific experienceOr

    Masters degreePreferred Qualifications:

  • M.S. in Mechanical Engineer, Chemical or Biomedical Engineering, or Chemistry
Excellent written and verbal communication skillsAbility to work in a highly matrixed team environment2 years of experience in the biotechnology/pharmaceutical industry2 years of experience in equipment, method, and mechanical designTechnical writing experienceExperience with SolidWorks (or other 3D-CAD software)Experience with combination products and regulatory requirementsExperience using Minitab (or other statistical software packages)Experience with machine controls (PLC, HMI) and vision systemsThrive

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.

The expected annual salary range for this role in the U.S. (excluding Puerto Rico) is posted. Actual salary will vary based on several factors including but not limited to, relevant skills, experience, and qualifications.

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, and flexible spending accounts.A discretionary annual bonus program, or for field sales representatives, a sales-based incentive planStock-based long-term incentivesAward-winning time-off plans and bi-annual company-wide shutdownsFlexible work models, including remote work arrangements, where possibleApply now

for a career that defies imagination

Objects in your future are closer than they appear. Join us.careers.amgen.comApplication deadline

Amgen does not have an application deadline for this position; we will continue accepting applications until we receive a sufficient number or select a candidate for the position.

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.

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