Senior Engineer, Combination Products - Process Engineering
Location: Cambridge
Posted on: June 23, 2025
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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. Senior Engineer What you will do Lets do
this. Lets change the world. In this vital role you will lead part
of development, and lifecycle management of manufacturing processes
for drug delivery drug/device combination products. This includes
technical operations support for design control activities, device
manufacturing, failure investigations, leading and assessing design
changes impact to manufacturing, developing test procedures,
leading scale-up and global launch, and continuous improvement.
Responsibilities of this position may include: Lead process
characterization of prefilled syringe delivery systems, including
packaging, labeling, and accessories. Lead process improvements,
conduct analytical failure analysis, and implement process
solutions. Author technical records and ensure they are
appropriately maintained in the e.g. Device Master record
(DMR)/Master Manufacturing Record (MMR) Author technical content in
Tech Transfer. Represent Process engineering within a large
network/matrix organization. Evaluate test methods, prototype
designs, and optimize products and processes using DOE and
statistical techniques. Monitor project progress, identify risks,
and implement mitigation strategies to ensure project landmarks and
timelines are met. Key player in fostering a collaborative and
innovative team environment to drive continuous improvement and
operational excellence. What we expect of you We are all different,
yet we all use our unique contributions to serve patients. The
engineering professional we seek will possess these qualifications.
Basic Qualifications: High school diploma / GED and 10 years of
Engineering and/or Operations experience; OR Associates degree and
8 years of Engineering and/or Operations experience; Or Bachelors
degree and 4 years of Engineering and/or Operations experience; Or
Masters degree and 2 years of Engineering and/or Operations
experience; Or Doctorate degree Preferred Qualifications:
Bachelor's degree in engineering or other science-related field
with 7 years of relevant work experience with 5 years of experience
in operations/manufacturing environment. Medical device industry
experience and regulated work environment experience. A background
in developing and commercialization of medical devices and
knowledge of manufacturing processes. At a minimum familiar with
the following standards and regulations: Quality System Regulation
21CFR820, Risk Management ISO 14971, EU Medical Device requirements
Council Directive 93/42/EEC. Strong understanding and experience in
design controls, failure investigation, initiating and bringing
complex projects to conclusion. Excellent communication and
technical writing skills. Ability to work independently and across
functional teams. S trong inter-personal and communication skills,
with the ability to effectively collaborate with diverse teams and
partners. Extensive knowledge of design controls and regulatory
requirements for medical devices and combination products.
Background in Combination product manufacturing processes and
knowledge of developing and commercializing medical devices.
Familiarity with standards and regulations such as Quality System
Regulation 21CFR820, Risk Management ISO 14971, and EU Medical
Device requirements Council Directive 93/42/EEC. Strong
understanding and experience in process failure investigation and
project management. Preferably have technical flair and are
familiar with technical drawings and construction. Demonstrated
proficiency in project management. Preferably have Strong
background in statistical analysis (experience with e.g. Minitab,
JMP is an advantage) Preferably have experience with Kistler
Maxymos monitoring systems. Strong problem-solving skills and the
ability to make sound technical decisions Ability to thrive in a
fast-paced, dynamic environment and manage multiple priorities.
What you can expect from 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,
including remote and hybrid work arrangements, where possible Apply
now for a career that defies imagination Objects in your future are
closer than they appear. Join us. 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. Application 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. 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. 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.
Keywords: , Attleboro , Senior Engineer, Combination Products - Process Engineering, Engineering , Cambridge, Massachusetts
