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Sr. Mfg Systems Engineer - Manufacturing Systems and Integrated Technologies

Employer
Amgen
Location
Thousand Oaks, California
Start date
Feb 16, 2024

Job Details

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.

Sr. Mfg Systems Engineer - Manufacturing Systems and Integrated Technologies

Live

What you will do

Lets do this. Lets change the world. In this vital role you will be part of our Clinical and Commercial Manufacturing Operations DTI 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 business partners to ensure product to patient. Which include our MES (Manufacturing Execution System), Clinical Label Printing, PI Data Historian, 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. You'll collaborate closely with cross-functional teams, including Manufacturing, Supply Chain, Quality, Operations DTI, and Enterprise Architects, to ensure seamless implementation and optimization of MES (Manufacturing Execution System), Historian Systems, and support partner with MCS automation / engineering for GLAM project support.

The role will be part of the Site OPS DTI team responsible for delivering systems in support of Clinical and Commercial Manufacturing in a product team.

  • Support Key DTI Manufacturing Systems operational and continuous improvements for Building 7 and ATO site.

  • Manage key system integrations (existing and new) streamlining manufacturing operations.

  • Champion business process improvements and help provide strategic digital initiatives leveraging established platforms, city plan technology and applications with Artificial Intelligence (AI).

  • On-Call Support, assisting in afterhours escalations / troubleshooting for DTI application issues.

  • Lead Major Incident and Problem Investigations, and Root Cause Analysis, Deviation Investigations, Corrective Actions, and 5-why root cause analysis.

  • Ensure Compliance: Maintain and update inspection readiness for critical applications, including inspection playbook, periodic assessments (data integrity, security, system compliance) Software Development Lifecyle (SDLC) Validation and testing.

  • Lead initiatives to introduce Industry v4.0 technologies to increase manufacturing efficiency and capacity.

  • Lead and train other team members to support operational excellence and multi-system competencies.

  • Support GMP and Partner audits as a system subject matter expert (SME) and act as support backup where required.

  • Support and lead CMDB (Configuration Management) updates / health. Support Service owner and managers to ensure up-to-date information.

  • Support site in assessment of impactful changes in weekly ATO CAB meeting.

  • Support Amgens Cyber resiliency efforts (Sentinels, ECR Network)

Win

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The dynamic professional we seek will have these qualifications.

Basic Qualifications:

Doctorate degree

OR

Masters degree and 3 years of Information Systems/System engineering experience

Or

Bachelors degree and 5 years of Information Systems/System engineering experience

Or

Associates degree and 10 years of Information Systems/System engineering experience

Or

High school diploma / GED and 12 years of Information Systems/System 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 DTI 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.

  • Large Scale Biotechnology, pharmaceutical, or healthcare experience

  • Strong leadership/consultative, collaboration, project management, service delivery and process improvement skills to facilitate alignment across multiple stakeholder groups.

  • Strong experience in business 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.

  • Excellent written, presentation, and verbal communication skills and technical expertise to be able to communicate effectively with business and technology partners, including demonstrated experience presenting technology recommendations with a business perspective.

  • Self-motivated individual who can effectively collaborate across a matrix organization and with proven ability to quickly learn new concepts and technologies and prioritize outcomes.

  • Demonstrated ability of leadership, collaboration, project management

  • Experience in technical writing and performing sophisticated root cause analysis of incidents/deviations and handling CAPA.

Thrive

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.

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 plan

  • Stock-based long-term incentives

  • Award-winning time-off plans and bi-annual company-wide shutdowns

  • Flexible work models, including remote 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

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.

Company

We are all different, yet we have this in common: our mission to serve patients. This sense of shared purpose is key to our becoming one of the world’s leading biotechnology companies. It guides us as we continue to launch new medicines and reach millions of patients worldwide.

We live the mission.

We win together.

We thrive on continual challenge.

Our team of 22,000+ scientists and professionals worldwide bring distinct perspectives and experiences to all we do. We leverage our global talent to achieve together—to research, manufacture and deliver ever-better products and greater depth to our mission.

At Amgen, there is a strong correlation between our high level of diversity and performance. Because addressing issues with a wider range of perspectives and approaches leads to more creative problem-solving. Together, we’re transforming the promise of science and biotechnology into therapies that have the power to restore health.

Connect with us to explore how you can Win, Live, and Thrive at Amgen.

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Company info
Website
Phone
805-447-1000
Location
Corporate Headquarters
One Amgen Center Drive
Thousand Oaks
California
91320-1799
United States

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