Engineer - Physical Methods
Company: Amgen
Location: Cambridge
Posted on: February 23, 2026
|
|
|
Job Description:
Join Amgens Mission of Serving Patients At Amgen, if you feel
like youre part of something bigger, its because you are. Our
shared missionto serve patients living with serious illnessesdrives
all that we do. Since 1980, weve helped pioneer the world of
biotech in our fight against the worlds 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, youll 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, youll thrive as part of the
Amgen team. Join us and transform the lives of patients while
transforming your career. Engineer Physical Methods What you will
do Lets do this. Lets change the world. The Engineer, in Physical
Methods, is 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 parts. 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 experienced support for qualification,
validation, transfer, and life cycle support of methods for
manufacturing, new product introduction, training, and production
support. Responsibilities: Method Lifecycle: Develop, qualify,
validate, and transfer 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 operational processes. Coordinate
test method development and delivery with selected contractors.
Provide experienced 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). Generate/author
and be responsible for the Test Method documents. Equipment
Lifecycle: Generate procedures necessary to support department and
new process equipment. Develop, integrate, and implement new
process technology and equipment. Assess, manage, and implement
equipment lifecycle changes. General: Implement projects per Final
Product Technologies and company procedures to ensure projects are
completed on schedule and within established budget. Provide
experienced support for investigations as well as new process
development required to improve manufacturing operations. 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. Participate in and assume
responsibilities of team functions as assigned (i.e. Product
Improvement Teams). 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
Align with the requirements, responsibilities, and authority as
required Maintains integrated timelines collecting appropriate
multi-functional details and work which are aligned with the
functional and project work Network 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 Drive multi-functional communication and integrate
information to optimize decision making, issue resolution and
change management throughout project lifecycle Demonstrate
excellent verbal and written communication skills are applied to
communicate project status and risks associated with integrated
timelines to leadership Collaborate with other functional leaders
to ensure project success, momentum and commitment Proactively
identify issues and/or risks and implement solutions that resolve
issues or increase efficiency. Integrate partner/vendor timelines
with Amgen timelines as appropriate 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. Basic Qualifications: High school diploma /
GED and 8 years of Engineering / Scientific experience OR
Associates degree and 6 years of Engineering / Scientific
experience OR Bachelors degree and 2 years of Engineering /
Scientific experience OR Masters degree Preferred Qualifications:
M.S. in Mechanical Engineer, Chemical or Biomedical Engineering, or
Chemistry Excellent written and verbal communication skills Ability
to work in a highly matrixed team environment 2 years of experience
in the biotechnology/pharmaceutical industry 2 years of experience
in equipment, method, and mechanical design Technical writing
experience Experience with SolidWorks (or other 3D-CAD software)
Experience with combination products and regulatory requirements
Experience applying Minitab (or other statistical software
packages) What you can expect of us As we work to develop
treatments that take care of others, we also work to care for your
professional and personal growth and well-being. From our
competitive benefits to our collaborative culture, well support
your journey every step of the way. 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. In
addition to the base salary, Amgen offers a Total Rewards Plan,
based on eligibility, comprising of 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 that may include: A 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 plan
Stock-based long-term incentives Award-winning time-off plans
Flexible work models where possible. Refer to the Work Location
Type in the job posting to see if this applies. Apply now and make
a lasting impact with the Amgen team. careers.amgen.com In any
materials you submit, you may redact or remove age-identifying
information such as age, date of birth, or dates of school
attendance or graduation. You will not be penalized for redacting
or removing this information. Sponsorship Sponsorship for this role
is not guaranteed. As an organization dedicated to improving the
quality of life for people around the world, Amgen fosters an
inclusive environment of diverse, ethical, committed and highly
accomplished people who respect each other and live the Amgen
values to continue advancing science to serve patients. Together,
we compete in the fight against serious disease. Amgen is an Equal
Opportunity employer and will consider all qualified applicants for
employment without regard to race, color, religion, sex, sexual
orientation, gender identity, national origin, protected veteran
status, disability status, or any other basis protected by
applicable law. 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.
Keywords: Amgen, Cambridge , Engineer - Physical Methods, Engineering , Cambridge, Massachusetts