Senior Manufacturing Systems Engineer Manufacturing Systems and Integrated Technologies
Company: Amgen
Location: Thousand Oaks
Posted on: March 29, 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.
Amgen is advancing a broad and deep pipeline of medicines to treat
cancer, heart disease, inflammatory conditions, rare diseases, and
obesity and obesity-related conditions. 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
Manufacturing Systems Engineer Manufacturing Systems and Integrated
Technologies What you will do Lets do this. Lets change the world.
In this vital role, you will be a part of our Clinical and
Commercial Manufacturing Operations Technology team, driving the
operation, refinement, and integration of cutting-edge
manufacturing applications. This role is an excellent opportunity
to gain an understanding of Amgens key manufacturing systems,
working with various MCS (Manufacturing and Clinical Supply)
business partners to ensure products to patients by managing and
supporting key computerized systems such as MES (Manufacturing
Execution System), Clinical Label Printing and Packaging, PI Data
Historian, Instrument Data Acquisition (IDA) and other integrated
systems. As a member of our team, you'll be the driving force
behind our mission to deliver high-quality products efficiently and
effectively. This role will be responsible for managing the MES
platform and associated integrations for the ATO site. In addition
to supporting key manufacturing operations, you will work closely
with the Global Instrument Data Acquisition (IDA) team to drive a
Global MES Standardization effort across all Amgen manufacturing
locations. This includes ensuring seamless integration of
instrument data, implementing standardized MES processes and
protocols, and collaborating with global stakeholders to align best
practices and compliance requirements. Your efforts will be
critical in optimizing manufacturing systems, enhancing data
integrity, and promoting consistency and efficiency across Amgens
worldwide network. You'll collaborate closely with cross-functional
teams, site business leads and plant leads that include
Manufacturing, Supply Chain, Quality, MCS Engineering, Enterprise
Architects, and MES/IDA Global Teams to ensure seamless
implementation and optimization of MES, PI Historian Systems, and
support partnering with MCS automation/engineering teams for GLAM
project support. The role will be part of the Site Operations
Technology team which is responsible for delivering systems in
support of Clinical and Commercial Manufacturing, working in a
client facing ATO site- focused approach. Responsibilities: Support
key TCT manufacturing systems by driving operational stability and
continuous improvements across Building 7, B20, B23, and the ATO
site. Manage key system integrations, both existing and new, to
streamline manufacturing operations. Champion business process
improvements and support strategic digital initiatives by
leveraging established platforms, city plan technology, and
artificial intelligence applications. Provide on-call support,
including after-hours escalations and troubleshooting for
operations technology application issues, aligned with 24x7
manufacturing requirements at the ATO site. Lead major incident and
problem investigations, including root cause analysis, deviation
investigations, corrective actions, and 5-why analysis. Ensure
compliance by maintaining and updating inspection readiness for
critical applications, including inspection playbooks, periodic
assessments for data integrity, security, and system compliance,
and SDLC validation and testing. Support regulatory inspections by
providing data, delivering presentations on site systems and
technology processes, and collaborating with subject matter experts
as needed. Lead initiatives to introduce Industry 4.0 technologies
to improve manufacturing efficiency and capacity. Lead and train
team members to support operational excellence and develop
multi-system competencies. Support and lead CMDB updates and system
health, ensuring accurate and up-to-date configuration data in
partnership with service owners and managers. Support the
assessment of impactful changes during weekly ATO Change Advisory
Board (CAB) meetings. Support Amgens cyber resiliency efforts,
including Sentinels and ECR Network initiatives. Provide on-site,
client-facing support at the ATO site up to five days per week,
based on business needs. What we expect of you We are all
different, yet we all use our unique contributions to serve
patients. The professional we seek is an individual with these
qualifications. Basic Qualifications: Doctorate degree OR Masters
degree and 2 years of Information Systems/Systems Engineering
experience OR Bachelors degree and 4 years of Information
Systems/Systems Engineering experience OR Associates degree and 8
years of Information Systems/Systems Engineering experience OR High
school diploma / GED and 10 years of Information Systems/Systems
Engineering experience Preferred Qualifications: BS/MS degree in
Information Systems, Computer Science, Engineering, or the Life
Sciences. 5 years experience in the biotech/pharmaceutical industry
and working with GxP computer systems in a regulated environment.
Experience with Amgen Technology Systems support and validation.
Database skills (queries, stored procedures, reports). Experience
with CDOCS, Application Lifecycle Management (ALM). Strong history
of analytical and troubleshooting skills. Experience with
ISM/AmgenNow is preferred. Work experience within biotechnology,
pharmaceutical, or healthcare. Strong leadership/consultative,
collaboration, project management, service delivery, and process
improvement skills to facilitate alignment across multiple
stakeholder groups. Strong experience in systems analysis. Ability
to work with business clients to understand their business
processes, manage scope of work/expectations, and suggest/recommend
IS solutions. Experience leading the IS change control process and
building, validating, and supporting GxP systems. Strong written,
presentation, and verbal communication skills and technical
expertise to be able to communicate effectively with business and
technology partners. Organization, with proven ability to quickly
learn new concepts and technologies and prioritize outcomes.
Experience in technical writing and performing root cause analysis
of incidents/deviations and handling CAPA. 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 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. 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. 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. 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.
Keywords: Amgen, Bellflower , Senior Manufacturing Systems Engineer Manufacturing Systems and Integrated Technologies, IT / Software / Systems , Thousand Oaks, California