Senior Engineer - Manufacturing Systems
Company: Amgen SA
Location: Thousand Oaks
Posted on: October 29, 2024
Job Description:
Join Amgen's Mission of Serving PatientsAt 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 Engineer -
Manufacturing SystemsWhat you will doIn this role as a member of
the Amgen Manufacturing & Clinical Supplies - Facilities &
Engineering (MCS-F&E) Automation team, you will support
Clinical and Commercial Drug Substance plant operations. This
includes complex and challenging system automation initiatives that
require understanding of various automation platforms, integration
between multiple platforms, analytical problem-solving techniques,
critical thinking, project management, lifecycle management and
Operational Excellence.Responsibilities include:
- Develop and maintain process control automation solutions
applying DeltaV Distributed Control System (DCS), Rockwell
Programmable Logic Controllers (PLC), Human Machine Interfaces
(HMI), Supervisory Control and Data Acquisition systems
(SCADA).
- Lead/support technical root cause analysis, incident
investigations, and troubleshooting on process control issues
related to plant operations.
- Own change control records, CAPA records and deviations as it
relates to Automation systems.
- Support functional area projects focused on improving process
equipment, cleaning systems and utilities to ensure reliability of
drug substance manufacturing facility.
- Lead and support new technology introductions by performing
automation engineering assessments, implementing automation system
configuration changes, and supporting engineering and process
qualification runs as applicable.
- Provide Continuous Improvement initiatives including Safety,
Reliability, Efficiency and Environmental sustainability
improvements to meet Amgen's Ambitious goals.
- Maintain Data Integrity Assessments with the current Amgen and
Industry standards.
- Support Review by Exception (RbE) functionality that includes
product Batch records, cleaning, and sterilization systems, Audit
trail and version control systems.
- Collaborate with Amgen Drug Substance Plant network to enhance
the automation design for Drug Substance Plant Operations.
- Be knowledgeable about compliance and regulatory aspects for
operation and maintenance, equipment validation, and support
regulatory inspections and audits.
- Day-to-day Operational Support including:
- Direct Manufacturing Support required for Critical
Operations.
- 24 x 7 Onsite/On Call as required.
- Troubleshooting Support to Manufacturing operations, cleaning
systems, plant utilities and Building management system.
- Automation System Administration.
- Automation System Operating Systems (OS) security patching and
HotFix assessments and rollout.
- Daily manufacturing and engineering work center team
meetings.
- Preventative and corrective maintenance.
- Automation System spare parts management.What we expect of
youThe automation professional we seek will possess these
qualifications.Basic Qualifications:
- Doctorate degree
- Or Master's degree and 2 years of Manufacturing Automation
Engineering experience
- Or Bachelor's degree and 4 years of Manufacturing Automation
Engineering experience
- Or Associate degree and 8 years of Manufacturing Automation
Engineering experience
- Or High school diploma / GED and 10 years of Manufacturing
Automation Engineering experiencePreferred Qualifications:
- Degree in Electrical Engineering, Chemical Engineering or
Biotech.
- Extensive understanding and background in programming, design,
installation, and lifecycle management of manufacturing process
controls, automation, and field instrumentation.
- Demonstrated hands-on experience in developing process control
strategies for New Product Introduction and New Technology
Deployment for Clinical and Commercial Drug Substance Plant
Operations.
- Familiarity with Upstream and Downstream unit operations.
- Direct knowledge of Automation design, experience in process
control engineering and troubleshooting with GMP biopharmaceutical
production facility equipment/systems.
- Demonstrated experience with continuous improvements resulting
in enhanced safety, system reliability, and efficiency related to
Drug Substance Plant Operations.
- Experience in Capital Project Lifecycle Management is a
plus.
- Strong leadership, technical writing, and
communication/presentation skills.
- Ability to perform independently, self-motivated, organized,
able to multi-task in project environments, and skilled in
communication, facilitation, and collaboration.3+ years' combined
experience with the following:
- Emerson Delta-V DCS system.
- Rockwell Automation SCADA and PLC Platform.
- Electronic Batch Reporting Systems Design and implementation
experience.
- Process Control Network design including network
segregation.
- Process Control Systems: Virtual Infrastructure design and
implementation.
- System Integration using OPC, Profibus, and DeviceNet
technologies.
- Compliance and regulatory requirements such as 21 CFR Part 11,
ASTM 2500, S88, S95 and GAMP.What you can expect from usAs 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, we'll
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.
- 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 nowfor a career that defies
imaginationJoin us.careers.amgen.comAmgen 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.
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Keywords: Amgen SA, Thousand Oaks , Senior Engineer - Manufacturing Systems, Other , Thousand Oaks, California
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