Principal Manufacturing Systems Engineer

BioSpace; Thousand Oaks (CA); On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Retirement and Savings Plan

Stock-based long-term incentives

Flexible work models where possible

Job summary

Amgen is seeking a Principal Manufacturing Systems Engineer to lead large, cross-functional programs across global manufacturing sites. You will apply program management and Agile practices to optimize OT platforms (AVEVA Pi, DeltaV, Rockwell) and drive lifecycle management, compliance, and continuous improvement.

This role partners with site and global stakeholders to deliver scalable, regulatory-ready solutions.

Qualifications

• Doctorate or equivalent with 2 years of Information Systems/Manufacturing Process Automation experience
• Masters with 4 years of Information Systems/Manufacturing Process Automation experience
• Bachelor's with 6 years of Information Systems/Manufacturing Process Automation experience
• Associate with 10 years of Information Systems/Manufacturing Process Automation experience
• High school diploma / GED with 12 years of Information Systems/Manufacturing Process Automation experience
• Experience with Aveva Pi, DeltaV, Rockwell, Korber MES and related OT tools
• Strong knowledge of GAMP, ANSI/ISA-S88 and S95, and 21 CFR Part 11
• Fluent in Agile methodologies; Product Owner/Scrum Master experience preferred
• OT-to-core system integrations (ERP, LIMS, historians) experience
• Strong communication and cross-functional collaboration skills

Responsibilities

• Lead large capital projects and product teams with Agile delivery in GMP environments
• Partner with site/global stakeholders to prioritize demand and balance local vs global needs
• Own financials, resource planning, vendor performance, and delivery against scope/schedule/quality
• Set global standards, templates, and best practices for OT project design and lifecycle management
• Ensure GMP compliance, data integrity, electronic batch records, and inspection readiness
• Coordinate cross-functional collaboration across site and corporate functions
• Own global OT roadmap including upgrades, standardization, site deployments
• Present status updates to senior leadership at governance meetings
• Maintain Agile backlog discipline and program roadmaps

Skills

Agile delivery

Program management

Stakeholder management

Financial management

Product Owner/Scrum Master

Education

Doctorate degree in IS/Manufacturing Automation

Masters degree in Information Systems/Manufacturing Automation

Bachelor's degree in Information Systems/Manufacturing Automation

Associate degree in Information Systems/Manufacturing Automation

High school diploma / GED with 12 years experience

Tools

Aveva Pi

DeltaV

Rockwell

Korber MES

ERP

LIMS

OT platforms integration

Job description

Join Amgens Mission of Serving Patients

At Amgen, if you feel like youre part of something bigger, its because you are. Our shared missionto serve patients living with serious illnessesdrives all that we do.

Since 1980, weve helped pioneer the world of biotech in our fight against the worlds 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, youll 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, youll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career.

Principal Manufacturing Systems Engineer

What you will do

Lets do this. Lets 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 Amgens 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 PMs, Platform SMEs, 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
• Masters degree and 4 years of Information Systems/Manufacturing Process Automation experience
• Bachelors degree and 6 years of Information Systems/Manufacturing Process Automation experience
• Associates degree and 10 years of Information Systems/Manufacturing Process Automation experience
• 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, well 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

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.

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.