Principal Manufacturing Systems Engineer

Amgen Inc. (IR); Thousand Oaks (CA); On-site; USD 160,000 - 217,000; Full time

Benefits offered by this job

Employee benefits package

Discretionary bonus

Stock-based incentives

Flexible work models

Job summary

Amgen Inc. in Thousand Oaks is seeking a Principal Manufacturing Systems Engineer to drive program success by applying project management and Agile methods across GMP manufacturing environments.

You will partner with business and technology leaders to align priorities and deliver optimized, quality outcomes. This role requires extensive experience with operations technology (Aveva Pi, DeltaV, Rockwell) and strong leadership to guide cross-functional teams, manage budgets, and advance a scalable

Qualifications

• Doctorate/Master/Bachelor/Associate/High school with specified years of Information Systems/Manufacturing Process Automation experience.
• Experience with manufacturing core systems and GMP environment is implied.
• Strong knowledge of Agile methodologies and product ownership roles.

Responsibilities

• Lead large capital projects and product teams with Agile delivery in GMP environments.
• Prioritize demand, manage backlogs, balance local vs global needs.
• Oversee financials, resources, vendors, and delivery against scope and schedule.
• Develop global standards and templates for operations technology projects.
• Ensure GMP compliance, data integrity, electronic batch records, and inspections readiness.
• Coordinate cross-functional teams across site and corporate functions.
• Own the global operations technology roadmap and deployment strategy.

Skills

Agile methodologies

Waterfall project management

Project management

Program management

Product Owner

Scrum Master

Education

Doctorate degree

Master's degree

Bachelor's degree

Associate's degree

High school diploma / GED

Tools

Aveva Pi

DeltaV

Rockwell

Korber MES

Digital Infrastructure

Advanced digital smart technologies

Job description

Career Category Information Systems 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. Amgen is advancing a broad and deep pipeline of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases, and obesity and obesity-related conditions. 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.

Principal Manufacturing Systems Engineer

Let's do this. Let's change the world. Does the thought of supporting most technologically advanced manufacturing sites globally excite you? Do you love building and developing high performing teams? If you are passionate and want to be a part of Amgen's mission to serve patients – every patient. Every time – then check out this exciting new opportunity. In this vital role, you will drive overall program success by applying program and project management principles to teams, partnering with business and technology leaders to ensure comprehensive alignment, and finding optimized ways to deliver efficiency and quality for our partners. We are seeking a Principal Manufacturing Systems Engineer with solid leadership skills in any of Amgen Manufacturing locations in the US or Europe to join our Ops Technology Manufacturing & Engineering team to help drive productivity through the company using technology to unlock opportunities to stop, optimize processes and then automate as appropriate. Are you someone that has extensive experience on the Operations technology (Aveva Pi, DeltaV, Rockwell, MES) and Program Management to take progressive project management approaches, Are you eager to take your program management, continuous improvement & SAFE-Agile, financial management skills and use them in creative new ways to build groundbreaking Operation smart technologies that helps develop life-changing biotech medicines?, If so, this may be the right place for you.

Responsibilities:

• Lead large capital project and product teams, by fostering Agile delivery while operating within GMP manufacturing environments.
• Partner with site and global stakeholders to prioritize demand, manage backlogs, and balance local needs with global strategy.
• Accountable for financials, resource planning, vendor performance, and delivery against scope, schedule, and quality targets.
• Drive global standards, templates, and best practices for large operations technology project/product design, deployment, lifecycle management and support to enable scalability and operational excellence.
• Ensure solution delivery meet GMP compliance, data integrity, electronic batch records, and regulatory inspection readiness.
• Lead cross-functional collaboration between site and corporate Operations, Quality, IT, OT, Automation, Platform Owners and external system integrators
• Own the global operations technology roadmap including upgrades, standardization, harmonization, and site deployments, aligned with business and regulatory requirements.
• Present status updates and progress to senior leadership at various governance meetings.

A day in the life:

• You are leading from the front engaging with business functions across the company to help deliver core manufacturing systems.
• Partnering with strategy group at Amgen and business partners to deliver initiatives.
• Lead a team of PM's, Platform SME's, Communication resources to ensure structure of how we operate within the program.
• Drive financial compliance/adherence of the program via the various projects.
• Own overall Program roadmap and communicate program status/milestones to executive leadership.
• Ensure product teams operate in the spirit of Agile and have backlogs that are being handled optimally.

What we expect of you

We are all different, yet we all use our unique contributions to serve patients. The Project manager, Program manager, Product Owner or Scrum Master professional we seek is an Agile methodology authority and traditional waterfall project management methodology with these qualifications.

Basic Qualifications:

Doctorate degree and 2 years of Information Systems/Manufacturing Process Automation experience OR Master's degree and 4 years of Information Systems/Manufacturing Process Automation experience OR Bachelor's degree and 6 years of Information Systems/Manufacturing Process Automation experience OR Associate's degree and 10 years of Information Systems/Manufacturing Process Automation experience OR High school diploma / GED and 12 years of Information Systems/Manufacturing Process Automation experience

Preferred Qualifications:

• Program/project/product management and delivery experience around manufacturing core systems like Aveva Pi, DeltaV, Rockwell, Korber MES, Digital Infrastructure, Advanced digital smart technologies etc.
• Solid understanding of GAMP software development lifecycle, ANSI/ISA-S88 and S95 industry standards and methodologies, 21 CFR Part 11.
• Fluent in Agile methodologies with respect to technology solutions and their development and timeline.
• Experience as a Product Owner or Scrum Master is preferred.
• Manage integration of OT platforms (MES, PI data etc) with core manufacturing and enterprise systems (ERP, LIMS, historians, automation layers such as DeltaV/Rockwell, and data platforms).
• Strong written and oral communication skills with scientific domain expertise to communicate effectively with various partners within the organization.
• Self-motivated individual with demonstrated ability to learn new concepts and technologies, work multi-functionally in teams (internal and external).
• Project Finance experience.
• You will have a consultant attitude, with the ability to clarify and control a diverse and shifting program lifecycle.
• Creativity and flexibility will be key components to excelling in this role.

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 where possible.

Refer to the Work Location Type in the job posting to see if this applies.

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.

Sponsorship

Sponsorship for this role is not guaranteed.

Amgen is an Equal Opportunity employer

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.

Salary Range 160,327.00USD -216,913.00 USD

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen