Senior Manufacturing Systems Engineer

Amgen SA; Holly Springs (NC); On-site; USD 143,000 - 165,000; Full time

Benefits offered by this job

Stock options

Retirement plan

Medical insurance

Life and disability insurance

Annual bonus

Stock-based incentives

Flexible work models

Job summary

Amgen seeks a Senior Manufacturing Systems Engineer to own the design and technology of the Manufacturing IS ecosystem, shaping roadmaps and driving automated solutions across SaaS, cloud, and on-prem platforms.

You will collaborate with business partners, manage IS projects, and lead POC initiatives to improve workflows and data integrity while ensuring compliance with 21 CFR Part 11 and GxP standards. A multi-year vision will guide your efforts.

Qualifications

• Bachelor’s degree (or foreign equivalent) in Mechanical Engineering or related field and 4 years of experience.
• Experience with Manufacturing Execution System (PASX) and MES upgrades.
• Experience with data integrations, SQL or web services.
• Familiarity with 21 CFR Part 11 and regulated environments.
• Experience designing, deploying automated solutions across SaaS, Cloud, On-prem and custom software platforms.

Responsibilities

• Own and shape the design and technology of the Manufacturing IS ecosystem.
• Collaborate with partners to develop a multi-year roadmap for applications.
• Manage and support IS projects with portfolio planning, resource and risk management and financial management.
• Lead POC automation efforts and improve workflows through automation.
• Align applications with architectural guidelines and cybersecurity requirements.

Skills

MES systems

SQL

Web services

21 CFR Part 11

Change control

Automation

Agile

Business analysis

Education

Bachelor’s degree in Mechanical Engineering

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.

Senior Manufacturing Systems Engineer

Duties: Own and shape the design and technology of the Manufacturing Information & Technology ecosystem; Collaborate with the business partners and other architects to develop a vision and multi-year roadmap for the advancement and lifecycle management of the applications; Manage and support the execution of a varied portfolio of IS projects with portfolio planning, resource and risk management and financial management for the portfolio; Work closely with the delivery and platform teams to ensure that the applications are aligned with standard city planning approved architectural and development guidelines; Lead selected efforts to design, build, and develop rapid Proof-of-Concept (POC) automated solutions and services; Collaborate with business partners to understand how automation can improve workflow and efficiency; Synthesize requirements from end-users, application architects, and cybersecurity experts to develop the best automation solutions; and Work closely with other business and IS Process Engineers to identify opportunities to stop inefficient practices, simplify business processes, and codify into automated solutions and platforms. May telecommute.

Requirements: Bachelor’s degree (or foreign equivalent) in Mechanical Engineering, Engineering or a related field & 4 years of experience in the job offered or in a project management-related occupation. Position requires 4 years of experience in the following:

Manufacturing Execution System (PASX), MES system enhancements and application upgrades;

Methods and technologies including SQL or Web Services to support Manufacturing Data integrations to enable automated data transfer and electronic batch record (EBR) review by exception;

Current GxP practices, including 21CFR Part 11 requirements in a regulated environment;

Change control process, system validation activities and compliance in computerized system lifecycle management;

Designing, developing, deploying, and operating automated solutions across SaaS, Cloud, On-prem and custom software developed platforms;

Developing technology solutions using agile methodology for improving business-training materials, processes, procedures related to databases, and reporting systems; and

Applying business analysis in translating high level business requirements into functional specifications and managing changes to such specifications and modification requests.

Job type: Full-Time position. The annual salary range for this position in the U.S. is $142,955.00 – 165,280.00 per year. Also, this position offers stock, retirement, medical, life and disability insurance and eligibility for an annual bonus or for sales roles, other incentive compensation. For more details visit https://careers.amgen.com/life-at-amgen/benefits/

What you can expect of 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

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.

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.