HOW MIGHT YOU DEFY IMAGINATION ?
You’ve 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 mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s 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
Let’s do this. Let’s 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 Amgen’s 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 ArtificialIntelligence (AI).
On-Call Support, assisting in afterhours escalations / troubleshooting for DTI application issues.
Lead Major Incident and Problem Investigations, and RootCauseAnalysis, Deviation Investigations, Corrective Actions, and 5-why rootcauseanalysis.
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 teammembers to support operational excellence and multi-system competencies.
Support GMP and Partner audits as a system subjectmatterexpert (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 Amgen’s 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
Master’s degree and 3 years of Information Systems/System engineering experience
Or
Bachelor’s degree and 5 years of Information Systems/System engineering experience
Or
Associate’s 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,projectmanagement, 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 verbalcommunicationskills 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.
Demonstratedability of leadership, collaboration,projectmanagement
Experience in technical writing and performing sophisticatedrootcauseanalysis 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,dentalandvisioncoverage,lifeanddisabilityinsurance, and flexiblespendingaccounts.
A discretionaryannualbonusprogram, 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.