Mfg Systems Engineer

Career Category

Job Description

Join Amgen’s Mission of Serving Patients

At 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.

Manufacturing Systems Engineer

Be part of Amgen's newest and most advanced drug substance manufacturing plant. When completed, the Amgen FleX Batch facility will combine the latest in disposable technologies with traditional stainless-steel equipment to allow for maximum flexibility in operations. The FleX Batch facility will not only feature the best in-class drug substance manufacturing technologies with embedded industry 4.0 capabilities, but it will also integrate sustainability innovations to reduce carbon and waste, as part of Amgen's plan to be a carbon-neutral company by 2027.

What you will do

Let’s do this. Let’s change the world. In this vital role you will be accountable for developing and continuously aligning the site manufacturing data ecosystem with rapidly changing business needs and Amgen Digital, Technology & Innovation (DTI) technical roadmaps.

Seeking candidates who possess expertise in business, and automation systems, information/data management and technical experience in database and data historian technologies and integration tools.

Responsibilities:

• Own and craft the design and technology of the DTI ecosystem.

• Support and/or be responsible for the execution of a varied portfolio of DTI and automation platforms projects with appropriate portfolio planning, resource, risk management and financial management for the portfolio.

• Crafting Amgen's future – Keep track of industry and technology trends, connect, and foster external networking opportunities to deliver valuable insight from other similar professionals in our industry!

• Support the cross-system analysis, feasibility analysis, scope projects, prioritize deliverables, and recommend optimal solution. Lead multiple initiatives and priorities.

• Effectively manage relationships with DTI service owners, business partners, enterprise DTI service partners, and vendors.

• Accountable to elicit and analyze needs identified by business stakeholders and convert them into functional design.

• Manage DTI platform activities including system administration, troubleshooting, vendor management, platform lifecycle and business requirements.

• Domestic and international travel up to 25%.

What we expect of you

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

Basic Qualifications:

Master’s degree

OR

Bachelor’s degree and 2 years of Information Systems, Engineering and/or Information technology experience

Or

Associate’s degree and 6 years of Information Systems, Engineering and/or Information technology experience

Or

High school diploma / GED and 8 years of Information Systems, Engineering and/or Information technology experience

Preferred Qualifications:

• 4+ years’ experience in a manufacturing environment with 2+ years of demonstrated ability in the Pharmaceutical or Biotechnology industries.

• 2+ years’ combined experience with the following product platforms: Data Historian (OSI PI), MES (Korber), and/or IS platforms.

• Experience and understanding of Information Systems infrastructure services, fundamentals, and operations (Storage, VMs, Network, Active Directory, etc.).

• General experience in methods and technologies to support Manufacturing Data integrations (e.g. SQL, Web Services/messaging, data mapping) is helpful.

• Experience working with Agile development methodologies.

• Ability to translate strategic opportunities and emerging technology solutions into tangible pragmatic executable plans allied to the ability to apply corporate blueprint and standards using business drivers to local business needs and project requirements.

• Ability to anticipate, evaluate and resolve multiple, simultaneous project issues, delays, and problems by applying technical, project management, and business expertise.

• Understanding of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards and methodologies to establish a PCS and MES implementation and Systems Integration that meets Operations' business requirements.

• Knowledge of industry standards for SDLC methodologies and 21 CFR Part 11.

• General experience with computer validation and change control methodology.

• Experience with computerized systems including troubleshooting, reliability, and performance improvements.

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, 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 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.

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